MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but discarded by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).
Event or Problem Description
It was reported that during an initial tka, the surgeon had difficulty implanting the articular surface and thus, a new one had to be opened and implanted.The second articular surface was implanted without any issues.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
The product was evaluated through photographic inspection and manufacturing review, however, the reported event could not be confirmed with the information provided.A photograph provided of the device exhibited a small usage mark, however, no further evaluation was possible.The device history records were reviewed and no discrepancies could be identified.A definitive root cause could not be determined with the information provided.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 further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9557348
• Report Number: 0001822565-2020-00079
• Device Sequence Number: 19418482
• Product Code: JWH
• UDI-Device Identifier: 00889024211148
• UDI-Public: (01)00889024211148
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K042271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00596203212
• Device Lot Number: 64316027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1