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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66 LPS AND S-ROM : KNEE FEMORAL

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DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MED RT 71X66 LPS AND S-ROM : KNEE FEMORAL Back to Search Results
Model Number 62-3401R
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
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
Delivery of all the instrumentation and implants, except the noiles femur implants. No possibility to troubleshoot around the clinic because the only depot is in other city (b)(6). Surgery initiated at 2pm and completed at 6pm. The surgeon made the decision to perform the surgery, performed the bone cuts and tests, then put a spacer in place for re-operation on (b)(6) 2022 with the removal of the spacer and the installation of the final implants. The implants were checked only at the time of the intervention by the j&j technical advisor, who warned the surgeon as soon as she had discovered it. The implant kits could not have been shown as missing on the delivery form as it was not reserved. Several elements involved, including the lack of staff of the team ready to sustain quality work.
 
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Brand NameSROM NRHFEM W/PIN MED RT 71X66
Type of DeviceLPS AND S-ROM : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key14218063
MDR Text Key290145773
Report Number1818910-2022-07627
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K896048
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 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number62-3401R
Device Catalogue Number623401R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/27/2022 Patient Sequence Number: 1
Treatment
SROM NRH FEM W/PIN XSMRT 66X58; SROM NRHFEM W/PIN MED RT 71X66; SROM NRHFEM W/PIN SM RT 66X62
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