MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF; KNEE TIBIA PROSTHESIS TRIAL, REUSABLE

Catalog Number	42527000505
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: canada.H6: component code : mechanical (g04) - provisional bottom.Complaint is confirmed via product review.Visual examination of the returned product found it to exhibit signs of repeated use and is fractured complaint was confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The ztr documents the summary of investigations for complaints associated with the tibial articular surface provisional (tasp) fracture.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.In addition to the visual and optical microscopy analysis, a review of the dhf and dfmea was performed.Ongoing complaint monitoring confirms that the rate of instrument fracture is within the expected risk profile as specified in the dfmea.A definitive root cause cannot be determined.
Event or Problem Description
It was reported that a tasp was worn to a point it was unable to be used but was later found to be fractured.No debris fell or was left in the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE EF
• Common Device Name: KNEE TIBIA PROSTHESIS TRIAL, REUSABLE
• 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: 18661458
• Report Number: 0001822565-2024-00449
• Device Sequence Number: 8240658
• Product Code: JWH
• UDI-Device Identifier: 00889024245006
• UDI-Public: (01)00889024245006(10)64197969
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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 Catalogue Number: 42527000505
• Device Lot Number: 64197969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• 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: 01/18/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown