MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ENDURON 10D 64OD X 28ID; HIP ACETABULAR INSERT/LINER

Catalog Number 124164025

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

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

Manufacturer Narrative

Examination of the returned liner does find evidence of poly material wear.Based on the information available it is believed the liner was implanted for more than ten years.No unusual wear for that length of time was identified.No oxidation as suggested by the surgeon was identified.A review of the device history records found no related deviations or anomalies.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not 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: ENDURON 10D 64OD X 28ID
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5808092
• MDR Text Key: 49954071
• Report Number: 1818910-2016-23587
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 124164025
• Device Lot Number: WUU-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/1999
• 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