MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 TOTAL HIP BALL 32MM +0; LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number	101467000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient was dislocated and brought to operation room.Liner and head removed.Severe lysis cleaned away and bone grafted in both pelvis and trochanter.A constrained liner was then cemented into the existing well fixed shell.Head had been implanted at 329915 on (b)(6), and the liner that was removed was implanted on (b)(6) at 160490.Doi: (b)(6) 2019 (head); (b)(6) 2019 (liner); dor: (b)(6) 2019; left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional 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 related reported incidents against the provided product code/lot number combination 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.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 +0
• Common Device Name: LARGE TAPER FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9084326
• Report Number: 1818910-2019-105329
• Device Sequence Number: 19497421
• Product Code: JDI
• UDI-Device Identifier: 10603295001256
• UDI-Public: 10603295001256
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K853655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101467000
• Device Lot Number: 7950666
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 08/28/2019; 11/28/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 09/20/2019; 11/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR