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

Model Number 1220-32-152

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that patient was revised due to poly wear.Doi: (b)(6) 2001.Dor: (b)(6) 2020.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The device was implanted in calendar year 2001.Poly material after this long implanted would not be 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.H10 additional narrative: added: d4 (lot #), d11, g5 and h4.Corrected: d1, d2b, d4 (catalog and udi).

• 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: 10523344
• MDR Text Key: 206582492
• Report Number: 1818910-2020-19903
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295015536
• UDI-Public: 10603295015536
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1220-32-152
• Device Catalogue Number: 124152025
• Device Lot Number: U2PFB1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +8.5 BL; DURALOC DYNAMIC LOCK RING 52MM
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 47