MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 16 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device identified that the dovetail feature was flared out and compressed.The device also exhibits damage in various areas on distal surface probably that happened during insertion.Device history record was reviewed and no discrepancies were found.The root cause is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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
It was reported that during a total knee arthroplasty, the tibial insert was warped during insertion and could not be implanted.No adverse events have been reported as a result of the malfunction.

• Brand Name: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 16 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10072638
• Report Number: 3007963827-2020-00139
• Device Sequence Number: 11700302
• Product Code: MBH
• UDI-Device Identifier: 00889024243163
• UDI-Public: (01)00889024243163(17)230831(10)64138505
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42522200616
• Device Lot Number: 64138505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/19/2020
• 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