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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 R; SIGMA KNEE PRIMARY : KNEE FEMORAL
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DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ2 R; SIGMA KNEE PRIMARY : KNEE FEMORAL Back to Search Results
Model Number 1960-50-200
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 08/12/2020
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
Patient was revised due to flexion instability with her previous knee replacement.Surgeon tightened her flexion gap with a tc3 femur, +2 bolt and tc3 rp insert.Doi: (b)(6) 2015 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.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
SIGMA PS CEM FEM SZ2 R
Common Device Name
SIGMA KNEE PRIMARY : KNEE FEMORAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10461207
Report Number1818910-2020-18940
Device Sequence Number2862337
Product Code JWH
UDI-Device Identifier10603295075110
UDI-Public10603295075110
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K073529
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/12/2020
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 Number1960-50-200
Device Catalogue Number196050200
Device Lot Number220648
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/12/2020
Supplement Date Received by Manufacturer09/22/2020
Initial Report FDA Received Date08/27/2020
Supplement Report FDA Received Date09/23/2020
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
PFC SIGMARP STB TB IN 2 17.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; PFC SIGMARP STB TB IN 2 17.5; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGTIBCEMSTM 13X30 1.5/2/2.5/3
Outcome Attributed to Adverse Event Required Intervention;
Patient Age34 YR
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