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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ2 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY
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DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ2 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY Back to Search Results
Model Number 1024-52-200
Device Problem Migration (4003)
Patient Problem Fall (1848)
Event Date 08/30/2021
Event Type  Injury  
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
Patient was revised for a collapsed tibial tray due to a fall.Extracted the uni femoral component, uni tibial tray and insert.Implant an attune rp revision tray with a 5mm wedge.An attune ps femur, 38 patella and an attune rp stabilize 5mm insert.There was no delay in surgery.There was no injury to patient.The original dos: (b)(6) 2021, dor: (b)(6) 2021, right knee.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received states that there was no extended time of surgery.The femur and insert were well fixed but extracted to go covert to a total knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received indicated that there was no delay in surgery.Depuy hv smart set gentamicin cement was use.Tibial insert and femur were well intact.
 
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Brand Name
SIGMA HP UNI TIB TRAY SZ2 RMLL
Type of Device
EARLY INTERVENTION : KNEE TIBIAL TRAY
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12496872
MDR Text Key272201312
Report Number1818910-2021-20513
Device Sequence Number1
Product Code HRY
UDI-Device Identifier10603295002383
UDI-Public10603295002383
Combination Product (y/n)N
PMA/PMN Number
K070267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1024-52-200
Device Catalogue Number102452200
Device Lot NumberJ70P62
Was Device Available for Evaluation? No
Date Manufacturer Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SIGMA HP UNI FEMORAL SZ2 RM/LL.; SIGMA HP UNI INS SZ2 7MM RM/LL.; SIGMA HP UNI TIB TRAY SZ2 RMLL.; UNK CEMENT SMARTSET MV.; SIGMA HP UNI FEMORAL SZ2 RM/LL; SIGMA HP UNI INS SZ2 7MM RM/LL; SIGMA HP UNI TIB TRAY SZ2 RMLL
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight84
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