MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DUR MAR +4 NEUT LNR 36X54; HIP POLY ACETABULAR LINERS

Catalog Number	122036454
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Patient was revised to address hip dislocation.Implanted a constrained liner and new head.Doi: (b)(6) 2013; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DUR MAR +4 NEUT LNR 36X54
• Common Device Name: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; depuy orthopaedics, inc. 18189; warsaw IN 46582 0988
• MDR Report Key: 7326696
• Report Number: 1818910-2018-54828
• Device Sequence Number: 16182974
• Product Code: LPH
• UDI-Device Identifier: 10603295015697
• UDI-Public: 10603295015697
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 122036454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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: 81 YR
• Patient Weight: 84