MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
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.Concomitant medical products: unknown tibial tray.Event occurred in the (b)(6).
Event or Problem Description
It was reported that during an initial tka, the articular surface failed to engage with the tibial tray during insertion.The surgeon attempted to free-hand impact the articular surface and when that failed, he had attempted to use the insertion instrument.At this point, the device was already deformed from the attempts and would not lock into place.An articular surface in the next size up was used and successfully implanted.There was no impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The event was unable to be confirmed due to limited information received from the customer.No product or images were provided.Review of the device history records identified no deviation or anomalies during manufacturing.A definitive root cause was unable to be determined.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 USE WITH PLATE 5,6 SIZE GREEN/C-H 10 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9836558
• Report Number: 0001822565-2020-00941
• Device Sequence Number: 16926510
• Product Code: JWH
• UDI-Device Identifier: 00889024208018
• UDI-Public: (01)00889024208018
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• 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): 06/23/2020

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: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00595204010
• Device Lot Number: 64242061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1