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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD METAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Laxity (4526); Physical Asymmetry (4573)
Event Date 03/17/2021
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 was revised due to length and stability.Doi: unknown, dor: (b)(6) 2021, (right 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 device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
UNK HIP FEMORAL HEAD METAL
Type of Device
METAL FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11628734
MDR Text Key244234802
Report Number1818910-2021-07301
Device Sequence Number1
Product Code JDI
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 03/17/2021
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? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD METAL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/17/2021
Initial Date FDA Received04/07/2021
Supplement Dates Manufacturer Received04/16/2021
Supplement Dates FDA Received04/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(52 MM DURALOC LINER); (METAL FEMORAL HEAD); (52 MM DURALOC LINER); (METAL FEMORAL HEAD)
Patient Outcome(s) Required Intervention;
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