MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 40IDX60OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122140460
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Ppf and sticker sheet received.Ppf alleges dislocation after first revision.Doi: (b)(6) 2014, dor: (b)(6) 2014, (right hip).
Additional Manufacturer Narrative
This is a duplicate report of 1818910-2014-33778.1818910-2019-104813 is being retracted as it is a report duplication.1818910-2014-33778 will be kept for investigation purposes.

• Brand Name: ALTRX +4 NEUT 40IDX60OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9072857
• Report Number: 1818910-2019-104813
• Device Sequence Number: 1984464
• Product Code: LPH
• UDI-Device Identifier: 10603295016618
• UDI-Public: 10603295016618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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 Expiration Date: 08/31/2017
• Device Catalogue Number: 122140460
• Device Lot Number: 273328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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: 80 YR