MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DURALOC CONST LINER 56/68X28; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number	124116527
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/22/2018
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
Der states patient has had a constrained liner in for approximately 14 years and was showing signs of wear.Surgeon noted how overly active patient was including playing on a trampoline.Constrained locking ring was disassociated from poly and there was black tissue surrounding implants.She had not dislocated in several months but she felt instability during ambulation.Doi: (b)(6) 2003; dor: (b)(6) 2018; unknown hip.
Additional Manufacturer Narrative
Product complaint # :(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DURALOC CONST LINER 56/68X28
• Common Device Name: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7352224
• Report Number: 1818910-2018-55495
• Device Sequence Number: 39498
• Product Code: KWZ
• UDI-Device Identifier: 10603295018735
• UDI-Public: 10603295018735
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P960054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• 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): 02/22/2018

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: 124116527
• Device Lot Number: VR4EC1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 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: 64 YR