MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN ALL POLY PAT COMP 32DIA; KNEE PROSTHESIS

Catalog Number	00597206532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with a history of unknown right total knee arthroplasty infection had a second stage revision performed.Subsequently, the patient was revised approximately 6 years post implantation due to instability.No further information has been provided at this time.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: st prc tib plt size 4, #item 00598003702, #lot j6537701, prc agmt block dist sz f 5mm, #item 00599003610, #lot 63974685, prc agmt block dist sz f 5mm, #item 00599003610, #lot 63832559, stem implant, #item 00598801013, #lot 64016153, stem implant, #item 00598801012, #lot 64358368, lcck fem implant sz f-r, #item 00599401692, #lot 64179221, ng lcck art sf, #item 00599403212, #lot 63447463, prc tib block 5mm sz4, #item 00-5988-004-26, #lot 63245817, prc tib block 5mm sz4, #item 00-5988-004-26, #lot 64146401.Therapy date: (b)(6) 2025.G2: foreign source country: australia.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4,b5,d2,g1,g3,g6,h1,h2,h3,h6.The cmp was not confirmed.- visual examination of the provided pictures identified explanted device with bone cement and foreign debris on the surfaces.As the implants were not returned, further evaluations could not be provided.- review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.- the reported products were reviewed for compatibility with no issues noted.- for the femoral, 12mm diameter stem, tibia, and patella: review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.- radiographs were provided and reviewed by a health care professional and it was determined further review would not enhance the investigation.- medical records were provided and reviewed by a health care professional.Review of the available records identified the following: initial / stage 2 revision op note demonstrate no intraop complications.- a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN ALL POLY PAT COMP 32DIA
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23895898
• Report Number: 0002648920-2025-00373
• Device Sequence Number: 5331710
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)270331(10)64358540
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 00597206532
• Device Lot Number: 64358540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Unknown