MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA MC TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 4-5 CD TOP; INSTRUMENT, KNEE

Catalog Number	42517100310
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product:tibial articular surface provisional left size cd: catalog#42517000303, lot#ni; multiple mdr reports have been filed for this report; please see associated report: 0001822565-2023-03418.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial total knee procedure, the tibial articular surface provisional instrument was chipped and unable to be inserted during the trialing process.There was no patient impact and no adverse events have been reported as a result of the malfunction.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, g3, h2, h3, h6.H6: suggested component code: mechanical (g04) - provisional top.The reported event was confirmed via provided photographs.Visual examination of the pictures identified the unit as chipped.A review of the device history records could not be performed as lot number was not provided.A definitive root cause could not be determined.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.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product:tibial articular surface provisional left size cd: catalog#42517000303, lot#65158058.The product has been received by zimmer biomet and prompted a review of the previously reported investigation results.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
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.The following sections were updated: b4, d9, g3, g6, h2, h6, h11.The complaint sample was returned, and visual examination of the product identified that it exhibited signs of repeated use and was worn, rather than fractured as originally reported.The root cause remains unchanged at this time.As the device was received worn, and no event of articular surface provisional wear has resulted in serious injury, zimmer biomet does not consider this event to be reportable.Additionally, 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 MC TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 4-5 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: 18256019
• Report Number: 0001822565-2023-03419
• Device Sequence Number: 12560581
• Product Code: MBH
• UDI-Device Identifier: 00889024238602
• UDI-Public: (01)00889024238602(10)65120752
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K150090
• 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,Followup,Followup
• Report Date (Section B): 07/29/2024

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: 42517100310
• Device Lot Number: 65120752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 12/29/2023; 02/20/2024; 07/02/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/02/2024; 03/14/2024; 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose