MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL-POLY PATELLA; PROSTHESIS KNEE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure twenty months post implantation due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femur cemented cruciate retaining (cr) catalog # 42502606402 lot # 65277059 tibia stemmed catalog # 42532007102 lot # 65303657 articular surface medial congruent (mc) catalog # 42522100812 lot # 65048458 stem extension tapered cemented catalog # 42557000114 lot # 65491613 unk palacos cement catalog # unknown lot # unk g2: australia customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.
Event or Problem Description
It was reported patient underwent a revision procedure twenty months post implantation due to pain.Attempts to obtain additional information have been made; however, no more is available.
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.Updated: b4, g3, g6, h2, h3, h4, h6, h10, and h11.Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: from per and follow up, reason for revision was pain, no additional medical records were provided.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: PERSONA ALL-POLY PATELLA
• Common Device Name: PROSTHESIS KNEE
• 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: 19689432
• Report Number: 0002648920-2024-00224
• Device Sequence Number: 7081093
• Product Code: MBH
• UDI-Device Identifier: 00889024247680
• UDI-Public: (01)00889024247680(17)270420(10)65346208
• 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: 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,Followup
• Report Date (Section B): 12/31/2024

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 Model Number: N/A
• Device Catalogue Number: 42540200029
• Device Lot Number: 65346208
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 12/31/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/30/2024; 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female