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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT
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DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT Back to Search Results
Model Number 5450-31-500
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Wound Dehiscence (1154); Pain (1994); Joint Contracture (4528)
Event Date 07/30/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 received a left attune total knee to treat osteoarthritis.The patella was resurfaced and depuy cement x 3 was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address pain, patella maltracking, contracture, open wound, and tibial tray and femoral component loosening at the cement to implant interfaces.The patella maltracking was corrected with a lateral retinacular release and sutures.The contracture was corrected with a posterior capsule release.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with depuy products and competitor cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017.Dor: (b)(6) 2018; left knee.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: device history reviewed 07 oct 19.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.(b)(4) units released.Expiry date: 28 feb 2019.
 
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Brand Name
DEPUY1 GENTAMICIN CEMENT 40G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12001161
MDR Text Key256277572
Report Number1818910-2021-12714
Device Sequence Number1
Product Code MBB
UDI-Device Identifier10603295174264
UDI-Public10603295174264
Combination Product (y/n)Y
PMA/PMN Number
K081163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Model Number5450-31-500
Device Catalogue Number545031500
Device Lot Number8277461
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ5 5MM; ATTUNE RP TIB BASE SZ 5 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 5 CEM; ATTUNE PS RP INSRT SZ5 5MM; ATTUNE RP TIB BASE SZ 5 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; SMARTSET GHV GENTAMICIN 40G
Patient Outcome(s) Required Intervention;
Patient Age60 YR
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