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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36-2; HIP INSTRUMENTS : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US ARTICUL TR BALL GRVD 36-2; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2531-50-000
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2021
Event Type  malfunction  
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 head trials have deep scratches.Found when set returned to the office for inspection.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.Device history review: a review of the as400, found the lot provided is not valid.
 
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Brand Name
ARTICUL TR BALL GRVD 36-2
Type of Device
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12154339
MDR Text Key261305694
Report Number1818910-2021-14994
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295129172
UDI-Public10603295129172
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 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2531-50-000
Device Catalogue Number253150000
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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