MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 9/10 ULTAMET 36MM HEADS +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962712000

Device Problem Corroded (1131)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 12/20/2018

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

The primary surgery was performed on (b)(6) 2011 via tha.It was reported that the patient complained pain from about 1 year ago and it had been progressing adduction of the stem during the follow-up observation.Thus, the revision surgery was performed on (b)(6) 2018 by replacing the insert (p/n: 121887356), the head (p/n: 962712000), the stem (p/n: 900527210) with sleeve (p/n: 550501).The cup (manufactured by (b)(4)) was not replaced, and two additional screws inserted.It was confirmed that adhesion of black powder at the head and the stem neck joint, degeneration of soft tissue, osteolysis of proximal part of femur.The stem and the sleeve were stuck together and did not separate when it was explanted.The surgery was completed without problems and there was no surgical delay.

Manufacturer Narrative

Product complaint : (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy considers the investigation closed at this time.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: 9/10 ULTAMET 36MM HEADS +3
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• 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, IN 19380-0988 ; 6103142063
• MDR Report Key: 8252290
• MDR Text Key: 133193744
• Report Number: 1818910-2019-81045
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962712000
• Device Lot Number: 3178548
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention