MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN COMPLETE KNEE SOLUTION; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	00597206532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 00596403210; lot# 65038731 item# 00598603702; lot# j6817421.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
It was reported that the patient underwent a revision approximately two (2) years and six (6) months post-implantation where only the patella and articular surface components were replaced.The physician suspected backside wear of the articular surface and tibia to be the cause.The patella also showed radiographic signs of bone lysis, so the surgeon wanted to replace it.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: a1; b4; b5; d2; g1; g3; g6; h1; h2; h10 d10: item# 00596403210; lot# 65038731 item# 00598603702; lot# j6817421 item# 00576401552; lot# 65022207 if any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection of the returned patella exhibits signs of use (discoloration and wear) and bone cement remains.Primary notes suggest no intra operative complication.Revision notes states that patient was revised due to pain, swelling, synovitis.During the surgery, wear was seen underside of articular surface with some micro marking on the tibial component too.However, the tibial component was well fixed and was not explanted.Review of the device history record identified no deviations or anomalies during manufacturing.Root cause cannot be determined.This complaint is confirmed via product returned, operative notes and photographs provided.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN COMPLETE KNEE SOLUTION
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED
• 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: 20344261
• Report Number: 0002648920-2024-00304
• Device Sequence Number: 12762429
• Product Code: JWH
• UDI-Device Identifier: 00889024215146
• UDI-Public: (01)00889024215146(17)300117(10)65270022
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2025

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: Health Professional
• Device Catalogue Number: 00597206532
• Device Lot Number: 65270022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 03/04/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/05/2024; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female