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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the upon applying range of motion on the knee, the provisional instrument fractured in half.Upon inspection of the fractured instrument, it was noted that it displayed significant wear and tear.The surgical technique was utilized.There was no surgical delay.No foreign bodies were retained.Another device was used to complete the procedure.Attempts have been made and all available information has been provided.
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
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.H6 : mechanical (g04) - provisional top.Visual examination of the returned product identified signs of repeated use (nicks, gouges) and the dovetail feature is flared & compressed.Confirming complaint is fractured all pieces returned.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.No further analysis can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were not provided.Device has a potential field age of over 7 years and exhibits signs of repeated use.The root cause of the event is attributed to wear and tear of the device from repeated use over time.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.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.

• Brand Name: PERSONA UC TIBIAL ARTICULAR SURFACE PROVISIONAL
• 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: 19466359
• Report Number: 0001822565-2024-01875
• Device Sequence Number: 7424358
• Product Code: JWH
• UDI-Device Identifier: 00889024238732
• UDI-Public: (01)00889024238732(10)63463280
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/23/2024

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: 42517200510
• Device Lot Number: 63463280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male