MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA MC VE ASF R; PROSTHESIS KNEE

Catalog Number	42522100813
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - medical product: psn tib por 2 peg sz e r catalog # 42530007102 lot # 65627625.G2: australia.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported patient underwent a revision procedure nineteen months post implantation due to tibial loosening, causing reduced congruency of bearing and instability.Tibial baseplate in situ shows delamination of the trabecular metal layer from the baseplate.No more information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g6; h1; h2; h3; h4; h6; h10; h11.Visual examination of the provided pictures identified that the tibial tray in situ with the articular surface removed.The tm appears to be delaminating from the underside of the tibial tray.The explanted tibial tray again shows the delamination of the tm from the tray and some bony ingrowth.The images of the explanted articular surface show signs of use such blood and damage around the inserter mating slot.As the devices were not returned and the explanting technique not noted, no further evaluation can be completed or conclusions made concerning damage to the product.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.This compliant cannot 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.
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.The following sections were updated: a1; b4; b5; b7; d9; g3; g6; h1; h2; h4; h6; h11.Visual examination of the returned product identified signs of use (pits, gouges, tool insertion marks).Dimensional analysis of the product determined that the product, where measured, was conforming to its print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA MC VE ASF R
• Common Device Name: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• 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: 22021237
• Report Number: 3007963827-2025-00195
• Device Sequence Number: 12922073
• Product Code: MBH
• UDI-Device Identifier: 00889024468443
• UDI-Public: (01)00889024468443(17)270411(10)65349299
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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
• Device Catalogue Number: 42522100813
• Device Lot Number: 65349299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 04/02/2026
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/21/2025; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown