MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD 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)
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 a tasp was returned fractured on a worn instrument claim form.All pieces have been returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by visual examination of the returned device.The device exhibited signs of repeated use and the medial side of the post was fractured off.All pieces were returned.Review of the device history records identified no deviations or anomalies during manufacturing.Previous investigations for this type of device malfunction concluded that the tasp fractures were from bending/torsional loading on the device.A device modification was made and this device was manufactured prior to the 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
No additional information at the time of this report.

• Brand Name: PS TIBIAL ARTICULAR SURFACE PROVISIONAL RIGHT SIZE 6-9 CD TOP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11101537
• Report Number: 0001822565-2020-04273
• Device Sequence Number: 3282826
• Product Code: JWH
• UDI-Device Identifier: 00889024245310
• UDI-Public: (01)00889024245310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2021

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: 42527400510
• Device Lot Number: 62985991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 04/06/2021
• 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: Z-2578-2014
• Patient Sequence Number: 1