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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL
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DEPUY ORTHOPAEDICS INC US UNK FEMORAL TRIAL Back to Search Results
Catalog Number UNK FEMORAL TRIAL
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2020
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 peg on the augment trial broke inside the femoral trial.Needs replacement to (b)(6) hold.
 
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.H10 additional narrative: added: b5.
 
Event Description
Additional information received indicated that the instrument broke into 2 pieces and were retrieved.There was no surgical delay.
 
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Brand Name
UNK FEMORAL TRIAL
Type of Device
FEMORAL TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10970038
MDR Text Key221247665
Report Number1818910-2020-26527
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK FEMORAL TRIAL
Device Lot NumberD1096
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/08/2020
Supplement Dates Manufacturer Received12/22/2020
Supplement Dates FDA Received12/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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