MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ALTRX +4 10D 36IDX52OD; HIP POLY ACETABULAR LINERS

Catalog Number 122136152

Device Problem Disassembly (1168)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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: unknown; dor: (b)(6) 2018; unknown side; no surgical delay.

Manufacturer Narrative

  (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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: ALTRX +4 10D 36IDX52OD
• Type of Device: HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7344660
• MDR Text Key: 102590281
• Report Number: 1818910-2018-55258
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016403
• UDI-Public: 10603295016403
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072963
• 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,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 122136152
• Device Lot Number: 344711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2018
• Date Device Manufactured: 02/21/2013
• 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: 62 YR