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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE STEM
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DEPUY ORTHOPAEDICS INC US UNK KNEE STEM Back to Search Results
Catalog Number UNK KNEE STEM
Device Problems Fracture (1260); No Apparent Adverse Event (3189)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2024
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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
It was reported that the femur stem failed.
 
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: a.Was there a surgical delay? what is the duration of the delay? no b.Were there any adverse consequence/s that affected the patient because of the reported event? no c.Is/are the product/s available for return? yes or no? yes d.Was there any revision surgery that occurred? if yes, please provide the details.Yes, s-rom hinge knee with sleeve & stem femoral and tibial with sleeve and stem e.What is the affected side involved in this event? left f.Please clarify the correct defective device(s) as the event description indicates stem, but a sleeve was reported.Kindly explain the specific defect of the devices.The thread of the +/- bolt has broken, please see the implants.
 
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 was received: let me just be clear that the main problem in this case is the fractured 0mm screw 960783 (j3187a).The 7deg adapter 960782 is automatically connected to this screw.
 
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Brand Name
UNK KNEE STEM
Type of Device
KNEE STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18705777
MDR Text Key335377793
Report Number1818910-2024-03257
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K060515
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/14/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK KNEE STEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MBT REVISION CEM TIB TRAY SZ 3; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ3 4MM; PFC*SIGMA DI AUG12MMCO,SZ3LEFT; PFC*SIGMA TC3 FEM LEFT SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 7 DEGREE; TC3 RP TIBIAL INSERT S3,25.0; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 75X14MM FLUTED
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexFemale
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