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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
2017-11-29Z-1052-2018Class IITerminatedThe LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.13,227 in totalclearance family
2017-11-29Z-1053-2018Class IITerminatedThe LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.13,227 in totalclearance family
2016-01-11Z-0837-2016Class IITerminatedLDPE bag containing the implant adheres to the highly polished implant surface.Distribution: Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada5103clearance family
2014-07-30Z-2545-2014Class IITerminatedInternal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.Distribution: Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.15 unitsclearance family
2013-08-30Z-0077-2014Class IITerminatedThe low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.Distribution: Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.5103clearance family
Regulatory clearances

    Predicate lineage

    K070695

    Cited as predicate by: K161592, K173057, K200122

    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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