MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 TOTAL HIP BALL 32MM +11; HIP METAL FEMORAL HEADS

Catalog Number 101470000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/04/2017

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 was revised for acute dislocation.The same implants were reimplanted.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TOTAL HIP BALL 32MM +11
• Type of Device: HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7154028
• MDR Text Key: 96024202
• Report Number: 1818910-2017-52708
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295001270
• UDI-Public: 10603295001270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K853655
• 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: 12/05/2017

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: 101470000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/26/2018
• Date Device Manufactured: 02/13/2012
• 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: 76 YR
• Patient Weight: 88