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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Off-Label Use (1494); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2021
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
The patient was revised due to stem subsided , took out and cemented back in we did change the head ball out.Doi: (b)(6) 2021 - dor: (b)(6) 2021 (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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN HIP FEMORAL STEM
Type of Device
HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12204785
MDR Text Key262737052
Report Number1818910-2021-15656
Device Sequence Number1
Product Code LPH
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 06/29/2021
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? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL STEM
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/29/2021
Initial Date FDA Received07/21/2021
Supplement Dates Manufacturer Received08/26/2021
Supplement Dates FDA Received08/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM
Patient Outcome(s) Required Intervention;
Patient Age88 YR
Patient Weight18
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