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); Tissue Damage (2104); Osteolysis (2377); No Code Available (3191)

Event Date 11/16/2018

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 the surgeon recognized that there was looseness on the patient's right hip joint, osteolysis on the cup of around screws.Also, there was suspected armd because of the liner and the head were sunk.Thus, the revision surgery was performed on (b)(6) 2018 by replacing the liner (p/n: 121887352), the head (p/n: 962712000), the stem (p/n: 900549210) with sleeve (p/n: 550502).There was no corrosion between the liner and the cup however, there was corrosion evidently between the head and the stem.The surgery was completed without any other problems.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the devices were reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
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> product code 962712000, lot number 2461279 was manufactured on 18 sep 2007.(b)(4) were manufactured per specification.There were no anomalies identified.If information is obtained that was not available for the initial medwatch, a follow-up 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, PA 19380-0988 ; 6103142063
• MDR Report Key: 8160372
• MDR Text Key: 130212932
• Report Number: 1818910-2018-78065
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2018

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: 2461279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 01/07/2019; 05/24/2019
• Supplement Dates FDA Received: 01/09/2019; 05/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2007
• 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: 88 YR