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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1961-92-022
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Wound Dehiscence (1154); No Code Available (3191)
Date of Event 08/10/2020
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for open incision: wound dehiscence.Event is serious and is considered mild.Event is definitely not related to both device and is possibly related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (left knee).Treatment: keflex and iodoform gauze.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.
 
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Brand Name
SIG RP AOX CRV INS SZ2.5 12.5
Common Device Name
SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10476562
Report Number1818910-2020-19154
Device Sequence Number2438973
Product Code NJL
UDI-Device Identifier10603295076131
UDI-Public10603295076131
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830055
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/14/2020
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
Operator of Device Health Professional
Device Model Number1961-92-022
Device Catalogue Number196192022
Device Lot Number9168039
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/14/2020
Supplement Date Received by Manufacturer10/05/2020
Initial Report FDA Received Date09/01/2020
Supplement Report FDA Received Date10/06/2020
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 2.5; DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM LT SZ 2.5
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
Patient Weight118
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