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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted. .
Event or Problem Description
It was reported via worn instrument return form that the trial articular surfaces were returned fractured.There are no events associated with the devices, they have out lived their usefulness.
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.Verified item lot combination and reviewed manufacturing date as returned item # 42527000510 lot # 64376251 exhibits signs of repeated use and has fractured on the medial side of the post feature all pieces were returned.The device history records for item # 42527000510, lot # 64376251 & receiving inspection report for item # 42527050510, lot # 80902186 were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Dhr supplier review found that the product was conforming to all specifications and no process deviations.A complaint history search identified 1 complaint for item # 42527000510 lot # 64376251 combination as of 31st august 2020.Complaints are monitored through monthly complaint review (reference (b)(4)) in order to identify potential adverse trends.A definitive root cause cannot be determined.Evaluation of the returned device identified the fracture was consistent with previous tasp fractures analyzed.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 no corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: CR TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 3-11 EF TOP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10425530
• Report Number: 0001822565-2020-02994
• Device Sequence Number: 2942960
• Product Code: JWH
• UDI-Device Identifier: 00889024245013
• UDI-Public: (01)00889024245013
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/18/2020

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: 42527000510
• Device Lot Number: 64376251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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