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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 UNKNOWN HIP FEMORAL STEM
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DEPUY FRANCE SAS - 3003895575 UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Loss of Osseointegration (2408)
Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 10/27/2020
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 there was a removal of total hip construct and placement of antibiotic spacer due to the presence of infection.It was also stated there was loosening of the femoral stem at the bone to implant interface.Doi: unknown, dor: (b)(6) 2020, left hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
MDR Report Key10811282
MDR Text Key215485515
Report Number1818910-2020-24247
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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