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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/28/2022
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
Patient was revised due to pain.Doi: (b)(6)2021.Dor: (b)(6)2022.Affected side: right 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.
 
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Brand Name
SROM NRHFEM W/PIN MED RT 71X66
Type of Device
LPS 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 Key14101651
MDR Text Key289174005
Report Number1818910-2022-06638
Device Sequence Number1
Product Code KRO
UDI-Device Identifier10603295179474
UDI-Public10603295179474
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K896048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number62-3401R
Device Catalogue Number623401R
Device Lot NumberJ5925N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2022
Initial Date FDA Received04/13/2022
Supplement Dates Manufacturer Received04/27/2022
Supplement Dates FDA Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2019
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
LPS UNIV TIB HIN INS MED 23MM; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 150X12MM FLUTED
Patient Outcome(s) Required Intervention;
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