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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 03/03/2020
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.(b)(4).
 
Event Description
Removed bipolar head and converted to competitor total.Reason for conversion is pain, no op notes and no further information provided.The only number legible on components removed was the 28+1.5 head ball.Doi: (b)(6) 2006, dor: (b)(6) 2020, right side.
 
Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
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Brand Name
UNKNOWN HIP FEMORAL HEAD
Type of Device
HIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key9849186
MDR Text Key184419193
Report Number1818910-2020-08486
Device Sequence Number1
Product Code KXA
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 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Date Manufacturer Received03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR POLY/METAL HEMI
Patient Outcome(s) Required Intervention;
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