MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL; 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	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).H6: proposed component (annex g) code is mechanical (g04) - provisional bottom.Reported event was confirmed by review of photograph provided.Visual evaluation of the provided device photograph shows signs of repeated use and the post feature has fractured.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A previous investigation into this issue determined that the likely root cause for the tasp fractures is bending/torsional loading on the device.A notification was sent to the field on august 7th, 2014 to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the device was fractured.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: 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: 17844068
• Report Number: 0001822565-2023-02670
• Device Sequence Number: 4401911
• Product Code: JWH
• UDI-Device Identifier: 00889024245044
• UDI-Public: (01)00889024245044(10)62683418
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/29/2023

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: 42527000707
• Device Lot Number: 62683418
• 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: 09/13/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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
• Patient Sex: Male