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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP FIXED REF POST ROT GDE 7DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

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DEPUY INTERNATIONAL LTD - 8010379 HP FIXED REF POST ROT GDE 7DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 9505-01-267
Device Problem Physical Resistance/Sticking (4012)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2020
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
During case the femoral sizer and the femoral posterior referencing femoral rotation guides were not going together easily.Then once we got it on it was extremely difficult to take off.Had to use a hohman to remove the femoral rotation guide.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned devices confirmed the reported event.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 : the current complaint sample was manufactured prior to the supplier corrective actions.
 
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Brand Name
HP FIXED REF POST ROT GDE 7DEG
Type of Device
KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key10741437
MDR Text Key213236529
Report Number1818910-2020-23384
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295225706
UDI-Public10603295225706
Combination Product (y/n)N
PMA/PMN Number
K170748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/12/2020
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 Model Number9505-01-267
Device Catalogue Number950501267
Device Lot NumberPG1109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2020
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received10/27/2020
Supplement Dates Manufacturer Received12/15/2020
Supplement Dates FDA Received12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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