MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR +4 NEUT 36IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936460
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/18/2017
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.
Event or Problem Description
Initial procedure, (b)(6) 2009 : total left hip replacement.Revision, (b)(6) 2010: conversion from metal to polyethylene implant.It was reported by legal that the patient experienced two left hip dislocation.On (b)(6) 2017 a closed reduction was performed on the patient, the physician noted some capsule contracture limiting external rotation.It was noted that on (b)(6) 2011 the patient did not have any recurrence of dislocation or pain.Devices involved: 1217-22-060 acetabular cup, sz 60, lot eh5eg1000.The 1219-36-460 pinnacle marathon, lot b64bl1000.The 1365-53-000 metal femoral head, lot 2717713.The 1217-20-500 cancellous bone screw, 428157.The 1217-20-500 cancellous bone screw, 421818.Related complaint (b)(4).
Additional Manufacturer Narrative
Investigation summary: 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: PINN MAR +4 NEUT 36IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7439412
• Report Number: 1818910-2018-57576
• Device Sequence Number: 13808378
• Product Code: LPH
• UDI-Device Identifier: 10603295014744
• UDI-Public: 10603295014744
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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 Expiration Date: 11/22/2012
• Device Catalogue Number: 121936460
• Device Lot Number: B64BL1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 58 YR