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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
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DEPUY ORTHOPAEDICS INC US SIGMA XLK CVD PLUS INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT Back to Search Results
Model Number 97-0451
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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
It was reported by the patient that she had a total knee replacement and scheduled for arthroscopic surgery on (b)(6), to see of there is anything that can be done to ease the pain and improve her range of motion, which is only 90 degrees and possible allergy to nickle.The customer also mentioned that she made a contact through email about three times but received no response.Doi: (b)(6) 2019.Dor: none reported; (unk knee).
 
Additional Manufacturer Narrative
Product complaint # (b)(4).The device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.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 XLK CVD PLUS INS 3 10MM
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 Key10600959
Report Number1818910-2020-21116
Device Sequence Number11667773
Product Code JWH
UDI-Device Identifier10603295250555
UDI-Public10603295250555
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K040166
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/16/2020
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 Number97-0451
Device Catalogue Number970451
Device Lot NumberJ4357K
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/16/2020
Supplement Date Received by Manufacturer11/09/2020
Initial Report FDA Received Date09/29/2020
Supplement Report FDA Received Date11/10/2020
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
DEPUY1 GENTAMICIN CEMENT 40G; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 3; SIGMA CR150 CEM SZ 3 RT; DEPUY1 GENTAMICIN CEMENT 40G; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 3; SIGMA CR150 CEM SZ 3 RT
Outcome Attributed to Adverse Event Required Intervention;
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