MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Approximately 11 months post implantation, the patient was revised due to pain, instability, and tibial subsidence.All components were exchanged.
Additional Manufacturer Narrative
(b)(4).Foreign source: australia.Concomitant medical products: 42532006702 - tibial component - 64831065, 42502806002 - femoral component - 64681685, competitor cement.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00221, 0001822565-2022-02528.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient complaints of pain and instability, no reported fall or incident.Revision surgery notes: operative diagnosis: subsidence and loosening right total knee.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is slight inferior subsidence of the tibial plate medially compared to the lateral positioning; no obvious abnormality with the hardware component of the femur; the lateral view does not provide any further details on subsidence; periprosthetic lucencies described above related to the tibial hardware, likely consistent with loosening; alignment otherwise normal.Overall fit appears normal.A definitive root cause cannot be determined.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING (CR) RIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15361585
• Report Number: 3007963827-2022-00222
• Device Sequence Number: 6023295
• Product Code: MBH
• UDI-Device Identifier: 00889024241558
• UDI-Public: (01)00889024241558(17)26030210)64966379
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 10/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 42522000410
• Device Lot Number: 64966379
• 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: 08/14/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG