MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the patient experienced polyethylene loosening occurred in the affected patient approximately 2 to 3 months after the implantation.It was found in the report that this loosening was caused by a mistake made by the surgeon during the implantation.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos confirmed the disassociation event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a positive identification of the unknown tibial tray product information was not visible from the photos provided.A manufacturing records evaluation (mre) was not performed as no lot number was provided or could be obtained from the photos of this device.Device history review : a positive identification of the unknown tibial tray product information was not visible from the photos provided.A manufacturing records evaluation (mre) was not performed as no lot number was provided or could be obtained from the photos of this device.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15536569
• MDR Text Key: 306376130
• Report Number: 1818910-2022-19412
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK ATTUNE KNEE TIBIAL INSERT (SIZE 7); UNK ATTUNE KNEE TIBIAL TRAY (SIZE 8)