MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. HYLAMER 10D 54OD X 28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 125154025

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 09/09/2014

Event Type  Injury  

Event Description

The patient was revised because of poly wear and pain.

Manufacturer Narrative

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.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.Additionally, research using the as400 system indicates that several pieces from the reported lots have been delivered, and, as no additional reports have been received, can be reasonably assumed implanted without issue.The report states polywear and pain after more than 16 years implantation.The patient is a reported 61 year old male with a calculated 43.1 bmi.The patient is considered morbidly obese.It is stated in the warnings and precautions that excessive patient weight tends to adversely affect hip replacement implants.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: HYLAMER 10D 54OD X 28ID
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4092286
• MDR Text Key: 21490112
• Report Number: 1818910-2014-28161
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/09/2014

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 Catalogue Number: 125154025
• Device Lot Number: R4HEV1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/1997
• 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: 61 YR
• Patient Weight: 132