MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 7-12 GH TOP; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
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 instrument fractured at an unknown time.No known impact or consequence to the patient.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Verified item lot combinations and reviewed manufacturing dates as returned item # 42527000610 lot # 63514375 exhibits signs of repeated use and has fractured on the medial side.All pieces were returned.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with the tasp fractures analyzed in a zrm.The zrm identified that the common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface, 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.
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 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 instrument broke post surgery.There was no patient involvement.

• Brand Name: CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 7-12 GH TOP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10421619
• Report Number: 0001822565-2020-02987
• Device Sequence Number: 2854103
• Product Code: JWH
• UDI-Device Identifier: 00889024245037
• UDI-Public: (01)00889024245037(11)161031(10)63514375
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2020

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: 42527000610
• Device Lot Number: 63514375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/24/2020; 09/28/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 08/25/2020; 09/28/2020
• 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