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

Catalog Number	42517000707
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical product: tibial articular surface provisional left size cd: catalog#42517000303, lot#64159154 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 a tibial articular surface provisional instrument fractured.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: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6; h9; h10.H6 : suggested component code: tasp bottom- mechanical (g04) - provisional bottom.Visual examination of the provided picture identified both devices to be fractured.Fragments are shown in the picture.No further evaluation can be made.The device history record was reviewed and no discrepancies relevant to the reported event were found.Medical records were not provided.Investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a previously addressed design issue.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH
• 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: 19143227
• Report Number: 0001822565-2024-01335
• Device Sequence Number: 18108206
• Product Code: JWH
• UDI-Device Identifier: 00889024238459
• UDI-Public: (01)00889024238459(10)64159154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/15/2024

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: 42517000707
• Device Lot Number: 62601574
• Was Device Available for Evaluation?: No
• 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: 07/03/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2014
• 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: Z-2578-2014
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Prefer Not To Disclose