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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 962710000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/16/2021
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
It was reported that the patient underwent the revision tha surgery on (b)(6) 2021. In the surgery, soft tissue degeneration and black powder around the neck and head interdigitation were confirmed. All the implants except a sleeve were removed. The cup was completely loose with no evidence of biological fixation. The adverse health effects due to this event were pain around the hip joint, discomfort, mental instability, and decreased hip function due to soft tissue degeneration. The doctor commented that the occurrence of reactive pseudotumor was due to artificial joint. This new information causes the removed depuy components to go from non reportable to reportable as they have been revised. The femoral head/stem were noted to have black powder (corrosion), the liner/head were the articulating surfaces and are being reported for the pseudotumor and soft tissue degeneration. The pain and discomfort may be attributed to the loosening and pseudotumor. The acetabular cup was noted to be a competitor cup.
 
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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 road
leeds LS11 8DT
UK LS11 8DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12712220
MDR Text Key278824476
Report Number1818910-2021-23907
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K982918
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number962710000
Device Lot Number3126267
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
Treatment
9/10 ULTAMET 36MM HEADS -3; COMPETITORS; PINNACLE MTL INS NEUT36IDX60OD; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM 9/10 18X13X140 36+8
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