MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY TALAR COMPONENT; ANKLE IMPLANT

Catalog Number UNK-EXTREM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable.

Event Description

Patient was revised to address pain, osteolysis and talar loosening, non-cemented.

Manufacturer Narrative

Conclusion and justification status for mdr: examination of the returned sp2 universal handle confirmed fracture at the square-to-circular (.183 dimension) cross-section changes of the distal end of the external rod sub-component.The overall condition of the instrument indicates heavy usage and impactions over time.A design modification to change to the undercut details of the square-to-circular (.183 dimension) cross-section was implemented in december 2012 via (b)(4) to reduce incidence of instrument failure.A search of the complaint database against product code 966520 did not find any reports of fracture manufactured after the december 2012 design modification.Although the submitted sp2 universal handle was manufactured prior to the design modification, it has been subjected to heavy usage and the root cause is attributed to normal use and servicing.The submitted sp2 universal handle was manufactured prior to the design modification in december of 2012 and the need for corrective action is not indicated.Monitor for reported events of fracture for sp2 universal handles manufactured after december 2012.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN DEPUY TALAR COMPONENT
• Type of Device: ANKLE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5171990
• MDR Text Key: 29178577
• Report Number: 1818910-2015-33504
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-EXTREM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 83