MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING LEFT 16MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified signs of attempted implantation (nicked/gouged).The locking feature (dovetail) is compressed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.This complaint was confirmed.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 surgical technique.The root cause is attributed to use error.
Event or Problem Description
It was reported the surgeon could not seat the tibia surface.No adverse events have been reported as a result of the malfunction.No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CRUCIATE RETAINING LEFT 16MM
• 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: 12422196
• Report Number: 3007963827-2021-00190
• Device Sequence Number: 14347703
• Product Code: JWH
• UDI-Device Identifier: 00889024235090
• UDI-Public: (01)00889024235090(17)240731(10)64481429
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512000416
• Device Lot Number: 64481429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/03/2021
• 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: 95