MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. ALTRX +4 10D 36IDX54OD; HIP ACETABULAR INSERT/LINER

Catalog Number 122136154

Device Problem Disassembly (1168)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); No Information (3190); No Code Available (3191)

Event Date 11/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical report states patient was revised to address disassociation.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update rec'd 01/08/2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient was bending over and felt their hip sublux and then pop back into place.Following that episode the hip was painful and squeaking.Upon revision black stained synovium was encountered; early metallosis of the synovial with metallic striping of the femoral ball.The liner was dislocated inferiorly.The ceramic femoral ball was articulating with the upper inner quadrant of the metal cup.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 01/27/2016.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other related reports against the product and lot code combinations since their release to distribution.Medical records were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: ALTRX +4 10D 36IDX54OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5335594
• MDR Text Key: 34687156
• Report Number: 1818910-2015-38206
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 122136154
• Device Lot Number: 482767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2016; 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2014
• 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: 66 YR
• Patient Weight: 106