MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 COMPLETE ULTAMET MTL 36IDX64OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887564

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Test Result (2695); No Code Available (3191)

Event Date 01/01/2019

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

Metal bearing surface exchange.Patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> high ion levels, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no, is the patient part of a clinical study --> no.

Manufacturer Narrative

(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COMPLETE ULTAMET MTL 36IDX64OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8907395
• MDR Text Key: 154777395
• Report Number: 1818910-2019-101468
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR