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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRVD 28+5; HIP INSTRUMENTS : FEMORAL TRIALS
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DEPUY ORTHOPAEDICS INC US ARTIC/EZE TR BALL GRVD 28+5; HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2530-82-000
Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(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 instrument has wear and tear.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.Corrected: h6 (device code).Material twisted/bent was updated to naturally worn.
 
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Brand Name
ARTIC/EZE TR BALL GRVD 28+5
Type of Device
HIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12228809
MDR Text Key263564717
Report Number1818910-2021-16073
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295128953
UDI-Public10603295128953
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2530-82-000
Device Catalogue Number253082000
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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