MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY SZ 6 CUSTOM TALAR COMPONENT; ANKLE IMPLANT

Catalog Number UNK-EXTREM

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address subsidence and talar component loosening at the bone/implant interface.Unknown cement was used.

Manufacturer Narrative

No device associated with this report was received for examination, however review of the provided x-ray confirms the reported event.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY SZ 6 CUSTOM TALAR COMPONENT
• Type of Device: ANKLE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7050736
• MDR Text Key: 92684347
• Report Number: 1818910-2017-29595
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 11/29/2017
• 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: 72 YR
• Patient Weight: 95