MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 42542006402 - tibia fixed non-porous right size c stem extension use required - 64207429n.Visual examination of the returned product/ provided pictures shows that the dovetail feature is compressed and the distal surface to exhibit damage (nicked gouged).The dhr was reviewed and no discrepancies relevant to the reported event were found.Damage to the articular surface can occur if the articular surface is not correctly placed and oriented before pushing it using the inserter instrument.Detailed instructions for inserting the articular surface are provided in the "persona revision knee system" surgical technique.The root cause is attributed to use error.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.
Event or Problem Description
It was reported the patient underwent right total knee arthroplasty.Subsequently, the patient experienced a traumatic accident resulting in a loose tibia.The patient was revised due to tibia loosening approximately 4 years post implantation.During the revision procedure, the surgeon had difficulty inserting the articular surface.Another articular surface was used.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11165118
• Report Number: 0001822565-2021-00156
• Device Sequence Number: 3616910
• Product Code: JWH
• UDI-Device Identifier: 00889024555075
• UDI-Public: (01)00889024555075(17)240131(10)64278054
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522800418
• Device Lot Number: 64278054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 01/13/2021
• 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 Weight: 82