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

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that an instrument is jammed and fractured.The instrument that clips under the tip of the instrument gets stuck once it is installed on it.It does not move from one side to the other once it is clipped.The mechanism that holds on the instrument is fractured.No additional information is available.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.Visual examination of the returned product identified signs of repeated use (nicked/gouged/discolored).The device was found to have the cam wing component disassembled from the hook component.The cam wing will no longer lock in the hook as the post is bent.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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 Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, d4, d9, g3, g6, h1, h2, h4, and h10.

Event Description

No further event information available at the time of this report.

• Brand Name: TIBIAL ARTICULAR SURFACE INSERTER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14830406
• MDR Text Key: 297074663
• Report Number: 0001822565-2022-01857
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024246423
• UDI-Public: (01)00889024246423(10)65040196
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42529900100
• Device Lot Number: 65040196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/05/2022; 09/28/2022
• Supplement Dates FDA Received: 08/23/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1