MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ALL POLY PAT VE 35 MM DIA; PROSTHESIS, KNEE

Catalog Number	42540200035
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an explant of left patella wires one year post implantation.No further information on the reason for the orif of left patella provided.Subsequently the patient was revised one year after the previous surgery due to an unknown fracture.The patella was exchanged.No further information provided.
Additional Manufacturer Narrative
(b)(4).D10: 42502206601 femur trabecular metal(cr) narrow porous lot# 65561053.42512000410 articular surface fixed bearing (cr) left 10 mm lot# 65567595.42532006701 tibia cemented 5 degree stemmed left size d lot# 65904632.42557000114 stem extension tapered cemented 14mm dia +30mm lot# 65943302.66056768 palacos r+g fast lot# 64731209.Ni cerclage wires (unk amount) lot# ni.The product will not be returned to zimmer biomet for investigation, as the device 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 submitted to relay additional information.The following sections were updated: a3a; b1; b2; b5; d1; d2a; d2b; d4; e1; g1; g3; h1; h2; h3; h4; h6.The reported event could not be confirmed due to lack of product/information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following.- op report for removal of previous orif wire of left patella.At the 4 corners wires were located, straightened and explanted without complications.(information around the event of the patella fracture not provided) (not calling out separate due to ongoing patella issue) - revision of patella for unk fracture no operative record provided.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history identified additional similar complaints for the reported item and1 similar complaint for the part and lot combination, however this complaint was not for a same or similar issue 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 ALL POLY PAT VE 35 MM DIA
• 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: 23061908
• Report Number: 0002648920-2025-00246
• Device Sequence Number: 21248471
• Product Code: MBH
• UDI-Device Identifier: 00889024247703
• UDI-Public: (01)00889024247703(17)280325(10)65915539
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: Lay User/Patient
• Device Catalogue Number: 42540200035
• Device Lot Number: 65915539
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown