MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURON 10D 52OD X 28ID; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Catalog Number 124152025

Device Problem Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2020

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

Revision of a duraloc liner and head exchange on the left hip.Original op date is unknown.Original liner has been in situ for over 20 years.Revision due to poly wear.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot # and udi), d6a, d10 and g4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2, d2b, d4 (catalog).

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.Although not returned poly material wear after approximately 20 years implanted is not unreasonable to expect.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a worldwide lot specific complaint database search, or device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: ENDURON 10D 52OD X 28ID
• Type of Device: DURALOC IMPLANT : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11266122
• MDR Text Key: 229848753
• Report Number: 1818910-2021-02258
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K944538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 124152025
• Device Lot Number: 00WPG46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; DURALOC 100 POLISHED 52 HA; S-ROM*HEAD FEMRL ZIRCONIA 28+6; S-ROM*SLEEVE PRX ZT HA 16D-LRG; SROM*STM ST,30+4L NK,16X11X150; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention