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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER; KNEE INSTRUMENT : ADAPTORS
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DEPUY ORTHOPAEDICS INC US MODIFIED HUDSON ADAPTER; KNEE INSTRUMENT : ADAPTORS Back to Search Results
Model Number 2178-63-136
Device Problems Material Twisted/Bent (2981); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
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 items were worn.All have been in service circa 8 years and have worn.No impact on patient.No delay to surgery.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 : lot information not available.
 
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Brand Name
MODIFIED HUDSON ADAPTER
Type of Device
KNEE INSTRUMENT : ADAPTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12154793
MDR Text Key261268451
Report Number1818910-2021-15005
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295096252
UDI-Public10603295096252
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 06/24/2021
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 Number2178-63-136
Device Catalogue Number217863136
Was Device Available for Evaluation? No
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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