MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 54MM; HIP ACETABULAR CUP

Catalog Number	121712054
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2015
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.
Event or Problem Description
Pinnacle revision, right hip.Reason for revision: pain and elevated metal ions.Update (b)(6) 2017: product stickers received.Updated lot number of liner.This complaint was updated on (b)(6) 2017.
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed at this time.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: PINN SECTOR HA ACET CUP 54MM
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7088149
• Report Number: 1818910-2017-29689
• Device Sequence Number: 19112257
• Product Code: LPH
• UDI-Device Identifier: 10603295009177
• UDI-Public: 10603295009177
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2016

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 Catalogue Number: 121712054
• Device Lot Number: CR6HHA000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2016
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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: 75 YR