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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 1581-13-112
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 10/23/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(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
The patient was dealing with some mid flexion instability that started roughly about a year ago.Dr.Had planned to perform an i&d poly exchange, increasing poly thickness and changing it to a curved plus insert.Once the knee was open, dr.Realized the tibial component was loose at the bone to cement interface.Cement manufacturer is unknown.He opted to remove the tibia, ream for a 14x75 stem, and implant a size 3 revision tibia with a 37 tibial sleeve.With leaving the femur, he trialed rp curved inserts and found the sz 4 17.5mm insert you be satisfactory.All the implants were opened and implanted.The knee was run through a range of motion and found to be stable.The closing process began.Doi: (b)(6) 2017, dor: (b)(6) 2020, right knee.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary =no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
SIGMA CRVD XLK INS 3 12.5MM
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 Key10816078
Report Number1818910-2020-24283
Device Sequence Number1127619
Product Code JWH
UDI-Device Identifier10603295063407
UDI-Public10603295063407
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/23/2020
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 Number1581-13-112
Device Catalogue Number158113112
Device Lot Number8218006
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/23/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date11/10/2020
Supplement Report FDA Received Date12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
SIG MOD TIB TRAY CEM COCR 3; UNK KNEE FEMORAL SIGMA; UNKNOWN BONE CEMENT; SIG MOD TIB TRAY CEM COCR 3; UNK KNEE FEMORAL SIGMA; UNKNOWN BONE CEMENT
Outcome Attributed to Adverse Event Required Intervention;
Patient Weight60
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