MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL INSERT; UNK ANKLE TIBIAL INSERT

Catalog Number UNK ANKLE TIBIAL INSERT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient underwent a revision of her right mobility ankle bearing due to pain and stiffness.Upon opening, the joint was stiff and had large amounts of fibrous tissue which seemed to be limiting movement.Mr (b)(6) removed the fibrous tissue and primary bearing, re-trialed the ankle with a trial bearing and then implanted a new size 2 - 3mm mobility ankle bearing (ref: (b)(4), lot:9440660).

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Corrected h6 patient code: no code available (3191) from the initial medwatch to capture patient harm musculoskeletal stiffness.

• Brand Name: UNKNOWN ANKLE TIBIAL INSERT
• Type of Device: UNK ANKLE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10144050
• MDR Text Key: 194843908
• Report Number: 1818910-2020-13651
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOB ANKLE BEAR 2 X 3MM; UNKNOWN ANKLE TIBIAL INSERT; MOB ANKLE BEAR 2 X 3MM; UNKNOWN ANKLE TIBIAL INSERT
• Patient Outcome(s): Required Intervention