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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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 during knee arthroplasty that the tibial articular surface provisional fractured upon insertion.Another device was used to complete the procedure.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; e1; g1; g3; g6; h1; h2; h3; h6; h8 corrections to e1 and h8.H6: proposed component (annex g) code is mechanical (g04) - provisional bottom the complaint is confirmed through the product return and evaluation.Visual examination of the returned product identified signs of repeated use (nicked or gouged).Additionally, the post feature was found to be fractured off, and not all pieces were returned.Medical records were not provided.A review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined; however, an internal technical report 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.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 is available at the time of this report.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE EF
• 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: 18975179
• Report Number: 0001822565-2024-00965
• Device Sequence Number: 17712057
• Product Code: JWH
• UDI-Device Identifier: 00889024238497
• UDI-Public: (01)00889024238497(10)63683230
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 42517000505
• Device Lot Number: 63683230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male