MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 MOB ANKLE BEAR 3 X 7MM; MOBILITY ANKLE SYSTEM : ANKLE TIBIAL

Catalog Number 955505307

Device Problem Insufficient Information (3190)

Patient Problems Osteolysis (2377); Not Applicable (3189)

Event Date 05/07/2018

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 appropriate.

Event Description

Exchange of liner - mobility ankle + calcaneal osteotomy + internal brace: (b)(6) 2018.As per surgeon - liner loose, ankle joint showing osteolysis.No primary date known.No further details available via surgeon or patient notes.On removal the liner appeared worn on the lateral aspect as would be expected looking at the x-ray.Jnj representative was present at the case.Female patient (b)(6).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: MOB ANKLE BEAR 3 X 7MM
• Type of Device: MOBILITY ANKLE SYSTEM : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7565116
• MDR Text Key: 109920653
• Report Number: 1818910-2018-61225
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

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: 955505307
• Device Lot Number: SA7871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 08/06/2018
• 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: 62 YR