MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ELITE PLUS LPW CUP 28/40; MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS

Catalog Number	965128040
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)
Date of Event	06/11/2018
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
The primary surgery was performed on 2005 via tha.It was reported that the revision surgery was performed on (b)(6) 2018 to revise the cup, the head, and the stem due to dissociation of the cup and the head.No further information was provided by the hospital.
Event or Problem Description
There was a surgery prolonged for less than 30 minutes.
Additional Manufacturer Narrative
(b)(4).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.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 28/40
• Common Device Name: MISCELLANEOUS HIP CUP/LINER : HIP POLY ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7663343
• Report Number: 1818910-2018-63741
• Device Sequence Number: 16584048
• Product Code: JDI
• UDI-Device Identifier: 10603295318521
• UDI-Public: 10603295318521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 965128040
• Device Lot Number: 2521448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/18/2018; 08/07/2018; 08/24/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 07/18/2018; 08/14/2018; 08/29/2018
• 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: 86 YR