MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CR TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 3-9 CD TOP; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2021
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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00259.
Event or Problem Description
It was reported the plastic post on the articulate trial had sheared off.No consequences or impact to the patient.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.During investigation, it was determined that the instrument was only worn, not fractured.Therefore, it was determined to be not reportable.The initial report should be voided.The returned tasp exhibits signs of repeated use (nicked or gouged) and the dovetail feature is flared but not cracked or fractured.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.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.

• Brand Name: CR TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE 3-9 CD TOP
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11252228
• Report Number: 0001822565-2021-00260
• Device Sequence Number: 3582825
• Product Code: JWH
• UDI-Device Identifier: 00889024238480
• UDI-Public: (01)00889024238480(11)190723(10)64265459
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 42517000410
• Device Lot Number: 64265459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 03/26/2021
• 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
• Patient Age: 55 YR
• Patient Weight: 68