MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DUR MAR NEUT LNR 32IDX54OD; DURALOC IMPLANT : HIP POLY ACETABULAR LINERS

Model Number 1220-32-054

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 02/18/2020

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.(b)(4).

Event Description

The patient was revised to address worn poly/painful.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020, left hip.

Manufacturer Narrative

H10 additional narrative: product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.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
=
> null.Device history batch
=
> null.Device history review
=
> null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DUR MAR NEUT LNR 32IDX54OD
• 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: 9792908
• MDR Text Key: 182171595
• Report Number: 1818910-2020-06916
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295015468
• UDI-Public: 10603295015468
• Combination Product (y/n): N
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1220-32-054
• Device Catalogue Number: 122032054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 70 YR