MAUDE Adverse Event Report: Zimmer Biomet, Inc. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM THICKNESS; Instrument, knee

Catalog Number	42527900502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a disassembled shim was returned.There was no patient involvement.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) the event is confirmed.Visual examination of the returned product identified signs of repeated use on all devices and the devices were conforming to specifications were measured.The results of each device evaluation identified both of the bearings and springs disassembled and missing.The device history record was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined.If any further information is found which would change or alter any conclusion or information, a supplemental report will be filed accordingly, zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 12 MM THICKNESS
• Common Device Name: Instrument, knee
• Manufacturer (Section D): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): Zimmer Biomet, Inc.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50063551
• Report Number: 0001822565-2026-02701
• Device Sequence Number: 18824042
• Product Code: MBH
• UDI-Device Identifier: 00889024245860
• UDI-Public: (01)00889024245860(10)64233265
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 42527900502
• Device Lot Number: 64233265
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown