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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
2013-11-05Z-0586-2014Class IITerminatedBased on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failureDistribution: Worldwide Distribution.42, 065 units totalclearance family
2013-11-05Z-0592-2014Class IITerminatedBased on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failureDistribution: Worldwide Distribution.42, 065 units totalclearance family
Regulatory clearances
  • 510(k)K130595Substantially equivalent (SESE) · 2013-09-17clearance family

Predicate lineage

Cited as predicate by: K181184

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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