MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED CRUCIATE RETAINING LEFT 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42512000512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Tissue Breakdown (2681); Joint Laxity (4526)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial tray: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni g2: foreign: australia.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Subsequently, eight (8) months post-implantation, the patient underwent revision surgery due to instability.The articular surface was exchanged without reported complication.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: unknown persona tibial tray porous size e: catalog#ni, lot#ni; unknown persona femoral component cr size 7: catalog#ni, lot#ni.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial left total knee arthroplasty.Subsequently, eight (8) months post-implantation, the patient underwent revision surgery due to instability.Ossification, ligament laxity, and soft tissue loss were noted intra-operatively.The articular surface was exchanged without reported complication.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided photographs identified scratches and gouges.The provided photograph is insufficient to complete an in-depth visual or dimensional analysis.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: femoral and tibial components in good position, extra ossificiation around the origin of the mcl, confirmed laxity in the coronal and sagittal plane suggesting soft tissue loss, most likely pcl attrition, revision for instability.Radiographs were not submitted for assessment at this time as physician's letter provides sufficient dictation of findings.A definitive root cause cannot be determined.The complaint is confirmed via medical records.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 available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED CRUCIATE RETAINING LEFT 12 MM HEIGHT
• 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: 18479150
• Report Number: 3007963827-2023-00359
• Device Sequence Number: 17790646
• Product Code: MBH
• UDI-Device Identifier: 00889024235137
• UDI-Public: (01)00889024235137(17)271114(10)65540574
• 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: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/24/2024

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: 42512000512
• Device Lot Number: 65540574
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 04/24/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/08/2024; 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male