MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIAL ARTICULAR SURFACE PROV LEFT SIZE CD; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmerbiomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported the trials were returned missing bearings on a worn instrument claim form.All pieces have returned.No patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h1, h2, h3, h6, h11 h6-component code- suggested code: mechanical (g04) - provisional bottom.Visual examination of the returned products/provided pictures and found it to exhibit signs of repeated use nicked / gouged / wear and the post has fractured off.Dimensional analysis of the products determined that the products, where measured, were conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Fractured tasps were analyzed by optical microscopy revealing hackle marks and river lines in the case of bending overload; and hackle marks, river lines and striations were found in the case of low cycle fatigue culminating in a bending overload failure type.This complaint can be confirmed based on the returned fractured item.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Upon review of our reporting decision on fracture of articular surface provisionals.A review of all complaints for this product indicates that there has never been an event that has resulted in a death or serious injury.Therefore, zimmer biomet will not be reporting this failure mode going forward.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROV LEFT SIZE CD
• 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: 19616172
• Report Number: 0001822565-2024-02151
• Device Sequence Number: 12506018
• Product Code: JWH
• UDI-Device Identifier: 00889024238459
• UDI-Public: (01)00889024238459(10)65158062
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 42517000303
• Device Lot Number: 65158062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose