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U.S. Department of Health and Human Services

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

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DEPUY INTERNATIONAL LTD. 8010379 9/10 ULTAMET 36MM HEADS +3 SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS Back to Search Results
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
==
> 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
==
> 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.
 
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Brand Name9/10 ULTAMET 36MM HEADS +3
Type of DeviceSMALL 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 Key8160372
MDR Text Key130212932
Report Number1818910-2018-78065
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
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
Date FDA Received12/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number962712000
Device Lot Number2461279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2018 Patient Sequence Number: 1
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