MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ELITE PLUS LPW CUP 28/43; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS

Model Number	9651-28-043
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
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
Der states that the patient had a total hip done 2005 in (b)(4), presents today with a cemented liner that spun out.We were requested to have 12/14 taper heads.Once patient's femoral head was removed the surgeon checked to see if the 12/14 articul eze would fit, it did not.It was loose on trunnion and would not engage at all.The surgeon tried other 12/14 heads and found zimmer 12/14 head fit very well, and was selected as the next implant.Doi: 2005; doe: (b)(6) 2017; unknown affected side.
Additional Manufacturer Narrative
Investigation summary no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELITE PLUS LPW CUP 28/43
• Common Device Name: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7163324
• Report Number: 1818910-2018-50121
• Device Sequence Number: 1903082
• Product Code: JDI
• UDI-Device Identifier: 10603295318538
• UDI-Public: 10603295318538
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 9651-28-043
• Device Catalogue Number: 965128043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 11/06/2018; 04/28/2020
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 11/06/2018; 04/30/2020
• 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: 56 YR
• Patient Weight: 60