MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. ASR ACETABULAR CUPS 56; HIP ACETABULAR CUP

Model Number	55-0513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
Event or Problem Description
Clinical der states that patient was revised to address periprosthetic osteolysis of the femur.
Additional Manufacturer Narrative
No device associated with this report was received for examination.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.Depuy considers the investigation closed.Should 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: ASR ACETABULAR CUPS 56
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD.; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6658250
• Report Number: 1818910-2017-19897
• Device Sequence Number: 16431683
• Product Code: KWA
• UDI-Device Identifier: 10603295175230
• UDI-Public: (01)10603295175230
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: 55-0513
• Device Catalogue Number: 999800756
• Device Lot Number: 1969281
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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: 63 YR
• Patient Weight: 79