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NexGen® Gender Solutions® 00-5752-017-05Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024191495), received between Nov 30, 2023 and Nov 30, 2023 — classified as 1 injury.

6 other recalls cover devices cleared under the same FDA submission (K072619, K173057); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT WAS REVISED NINE MONTHS POST IMPLANTATION DUE TO UNKNOWN REASON. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Insufficient Information

    MAUDE report 18237164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072619, K173057. One submission often covers many models, so check the product and lot details in each record.

  • Z-2092-2023 · May 19, 2023 · Terminated
    NexGen Precoat Stemmed Tibial Plate Size 5
  • Z-0321-2020 · Oct 10, 2019 · Terminated
    Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
  • Z-1057-2018 · Nov 29, 2017 · Terminated
    NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthrit
  • Z-1044-2018 · Nov 29, 2017 · Terminated
    LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FL
  • Z-0840-2016 · Jan 11, 2016 · Terminated
    CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/p
  • Z-0609-2011 · Apr 16, 2010 · Terminated
    NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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