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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2012-02-24Z-1547-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1548-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1549-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1550-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1551-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1552-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1553-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1554-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1555-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
2012-02-24Z-1556-2012TerminatedZimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation identified additional instances where a CR micro articular surface and standard CR femur were sold together on the same purchase order. CR micro articular surfaces are—clearance family
Showing 1–10 of 50
Regulatory clearances

    Predicate lineage

    K951185

    Cited as predicate by: K173057

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2022-07-27NAINo action indicatedZimmer, Inc.0
    2022-07-27NAINo action indicatedZimmer, Inc.0
    2020-10-01NAINo action indicatedZimmer Manufacturing B.V.0
    2017-10-16VAIVoluntary action indicatedZimmer, Inc.8
    2017-10-16VAIVoluntary action indicatedZimmer, Inc.8
    2017-09-01NAINo action indicatedZimmer Trabecular Metal Technology, Inc.0
    2017-07-27VAIVoluntary action indicatedZIMMER ORTHOPEDIC MFG LTD3
    2017-07-20VAIVoluntary action indicatedZimmer Manufacturing B.V.3
    2016-05-27WLWarning LetterOrthosoft, Inc.—
    2016-05-23VAIVoluntary action indicatedZimmer Surgical Inc4
    2015-11-20OAIOfficial action indicatedZimmer, Inc.10
    2015-11-20OAIOfficial action indicatedZimmer, Inc.10
    2015-11-17VAIVoluntary action indicatedZimmer Manufacturing B.V.4
    2015-05-11VAIVoluntary action indicatedZimmer Trabecular Metal Technology, Inc.3
    2014-10-16VAIVoluntary action indicatedZIMMER ORTHOPEDIC MFG LTD2
    2014-06-11OAIOfficial action indicatedZimmer Manufacturing B.V.9
    2014-05-28OAIOfficial action indicatedZimmer, Inc.12
    2014-05-28OAIOfficial action indicatedZimmer, Inc.12
    2014-02-07VAIVoluntary action indicatedZimmer, Inc.2
    2014-02-07VAIVoluntary action indicatedZimmer, Inc.2
    2013-08-19OAIOfficial action indicatedZimmer, Inc.0
    2012-09-19WLWarning LetterZimmer Manufacturing B.V.—
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