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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 18X13X140 36+8; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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DEPUY INTERNATIONAL LTD - 8010379 SROM 9/10 18X13X140 36+8; S-ROM HIP SYSTEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 900551210
Device Problem Degraded (1153)
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.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
 
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Brand Name
SROM 9/10 18X13X140 36+8
Type of Device
S-ROM HIP SYSTEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg ringaskiddy co.
cork LS11 8 DT
EI   LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key12712244
MDR Text Key278824737
Report Number1818910-2021-23909
Device Sequence Number1
Product Code LWJ
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
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? Yes
Device Operator Health Professional
Device Catalogue Number900551210
Device Lot Number2967447
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 Manufactured07/14/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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; 9/10 ULTAMET 36MM HEADS -3; COMPETITORS; PINNACLE MTL INS NEUT36IDX60OD; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM 9/10 18X13X140 36+8
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight84 KG
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