MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 COMPLETE ULTAMET MTL 36IDX52OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887552

Device Problem Naturally Worn (2988)

Patient Problems Inflammation (1932); Pain (1994); No Code Available (3191)

Event Date 01/01/2020

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

Hip metal debris.Groin pain.Left hip.

Manufacturer Narrative

Product complaint # (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, post market surveillance, 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.

• Brand Name: COMPLETE ULTAMET MTL 36IDX52OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10048287
• MDR Text Key: 190664112
• Report Number: 1818910-2020-11978
• Device Sequence Number: 1
• Product Code: OVO
• Combination Product (y/n): N
• PMA/PMN Number: P090002
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121887552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5; COMPLETE ULTAMET MTL 36IDX52OD; ARTICULEZE M HEAD 36MM +1.5; COMPLETE ULTAMET MTL 36IDX52OD
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 107