MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX56OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132056
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	04/24/2018
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
The patient was revised to address disassociation.Doi: (b)(6) 2017; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Product complaint # = > pc-(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: ALTRX NEUT 32IDX56OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7532728
• Report Number: 1818910-2018-60160
• Device Sequence Number: 13511267
• Product Code: LPH
• UDI-Device Identifier: 10603295016137
• UDI-Public: 10603295016137
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K062148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/24/2018

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: 122132056
• Device Lot Number: H04467
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/27/2018
• 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: 52 YR
• Patient Weight: 106