MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 CD TOP; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and 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 that a fractured provisional was received via the worn instrument return program.There was no reported patient involvement.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Proposed component (annex g) code is mechanical (g04) - provisional top.Performed a visual inspection of the returned product found it to exhibit signs of repeated use nicked / gouged and a chunk of the post feature has fractured off all pieces were not returned.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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.Complaint is confirmed via product review.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.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-5 CD TOP
• 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: 18345238
• Report Number: 0001822565-2023-03646
• Device Sequence Number: 6222424
• Product Code: JWH
• UDI-Device Identifier: 00889024245303
• UDI-Public: (01)00889024245303(10)63533541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: 42527400410
• Device Lot Number: 63533541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ZTR WA 0820 20.
• Patient Sequence Number: 1
• Patient Sex: Unknown