MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA ARTICULAR SURFACE FIXED PS RIGHT 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	42522400910
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.Subsequently, the patient exhibited instability in flex and extension.The patient then underwent revision surgery to exchange the articular surface and implant a thicker bearing.It was reported that no further information is available.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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: PERSONA ARTICULAR SURFACE FIXED PS RIGHT 10 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: 19016134
• Report Number: 3007963827-2024-00091
• Device Sequence Number: 3809696
• Product Code: MBH
• UDI-Device Identifier: 00889024243910
• UDI-Public: (01)00889024243910(17)270706(10)65411175
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/31/2024

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: 42522400910
• Device Lot Number: 65411175
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male