MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-11 EF TOP; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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
It was reported that the tasp was found broken during washing cycle.There was no patient involvement.
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.Visual inspection of the returned item # 42527000510, lot # 63432801 found it to exhibit signs of repeated use, nicked gouged, and worn.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-11 EF TOP
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12269214
• Report Number: 0001822565-2021-02179
• Device Sequence Number: 5061495
• Product Code: JWH
• UDI-Device Identifier: 00889024245013
• UDI-Public: (01)00889024245013(10)63432801
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 42527000510
• Device Lot Number: 63432801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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