MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2 : foreign country : canada.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 that upon opening the case, the scrub nurse realized that some shims were missing some bearings.All available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified that the shims are disassembled, with parts visibly separated.The images show the beads (ball bearings) mentioned in the reported event, are missing from the assemblies.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.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.
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: b4; b5; d9; g3; g6; h1; h2; h3; h6; h11 visual evaluation of the returned products identified that the products exhibit signs of use (nicked or gouged) and both of the ball bearings are missing (missing ball bearings are not returned).Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.The investigation remains the same as previous.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.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
• 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 ; 5745260384
• MDR Report Key: 20189532
• Report Number: 0001822565-2024-02909
• Device Sequence Number: 17840776
• Product Code: MBH
• UDI-Device Identifier: 00889024245761
• UDI-Public: (01)00889024245761(10)63967557
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/18/2025

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527900302
• Device Lot Number: 63967557
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 06/18/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/06/2024; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown