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

Catalog Number 122132056

Device Problem Disassembly (1168)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address disassociation.Doi: (b)(6) 2017; dor: (b)(6) 2018; right hip.

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
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7532728
• MDR Text Key: 108855015
• Report Number: 1818910-2018-60160
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016137
• UDI-Public: 10603295016137
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 122132056
• Device Lot Number: H04467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/27/2018
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 106