MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ROTATING HINGE SIZE 4 PRECOAT CEMENTED TIBIAL COMPONENT; PROSTHESIS, KNEE

Catalog Number	00588000400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: 14mm height size f articular surface with hinge post extension: catalog#00588006014, lot#64649674; cement shield hinge service kit size f: catalog#00585007516, lot#64812403; right size f cemented option femoral component: catalog#00588001602, lot#64695386; 15mm diameter 30mm length straight stem extension combined length 75mm: catalog#00598801215, lot#64560563; all poly patella cemented 35mm diameter: catalog#42540000035, lot#64995552; unknown stryker cement: catalog#ni, lot#ni, qty#3; unknown stryker cement restrictor: catalog#ni, lot#ni, qty#2.The product will not be returned to zimmer biomet for investigation, as the product currently remains implanted.The investigation is in process.Upon completion of the investigation, a follow-up mdr be submitted.
Event or Problem Description
It was reported that a patient had a right total rotating hinge knee arthroplasty performed and subsequently underwent two revision surgeries due to disassociation of the hinge post extension as well as a quadriceps tendon repair procedure.It was reported that the patient has continued to experience significant pain which interferes with ambulation and daily activities for two (2) years following the most recent procedure.No additional medical intervention has been reported to date to address the continued pain.All available information has been reported.
Event or Problem Description
No additional information to report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h3, h6 h10: multiple reports were submitted for this event.0001822565-2024-03385.0001822565-2024-03388.0002648920-2024-00333.0002648920-2024-00334.0001822565-2024-03386.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Operative notes were provided and reviewed by an hcp stating that the patient had underwent an initial right total rotating hinge knee arthroplasty and subsequently underwent 2 revisions to address disassociation of the poly and hinge component, which caused instability.Three weeks after the second revision, the patient returned to surgery for a quadriceps tendon report.Legal documents confirm the patient continues to experience severe pain, significant difficulties with ambulation, and decreased ability to perform daily activities, which have been ongoing for more than 2 years postoperatively.These ongoing symptoms are classified as a serious injury due to their prolonged impact on the patient's quality of life.The reported event is not confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.According to the instruction for use "nexgen® complete knee solution - rotating hinge knee" (87-6203-904-99 en rev.G), "to properly match the components, the femoral and tibial component size must both be reflected on the articular surface label.Mismatching may result in poor surface contact and cause pain, greater wear, implant instability, or otherwise reduce implant life." additionally, the "nexgen® rh knee primary/revision surgical technique" (97-5880-002-00 rev0220) outlines compatible combinations.However, 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated/corrected: b4; b5; d10; g3; h2; h11.D10: corrected concomitant medical product: articular surface with segmental hinge post size f 14 mm height: catalog#00585006014, lot#64649674.Additional information provided does not alter previously reported investigation results.If any further information is found 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 at time of this report.

• Brand Name: ROTATING HINGE SIZE 4 PRECOAT CEMENTED TIBIAL COMPONENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20523453
• Report Number: 0001822565-2024-03387
• Device Sequence Number: 18172481
• Product Code: JWH
• UDI-Device Identifier: 00889024199026
• UDI-Public: (01)00889024199026(17)260601(10)65069785
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 00588000400
• Device Lot Number: 65069785
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 02/03/2025; 03/05/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/04/2025; 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male