MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA A/P CVD TB 8MM,SZ 5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-0660
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
Date of Event	06/17/2013
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
On (b)(6) 2013, the patient underwent a primary left knee arthroplasty due to osteoarthritis.Depuy sigma knee implanted with three depuy cement products.The surgeon noted after cementation of the all-poly tibia, there was some bleeding from a lateral side of the joint in the lateral gutter.The site was inspected, and it was found to be inferolateral geniculate artery with bleeding.Multiple attempts were made to cauterize the bleed, but although the bleeding slowed significantly the surgeon was unable to get it completely with the knee in extension or in flexion.The surgeon elected to explant the tibial component to gain access to the bleeder, so the all-poly tibial tray was removed with an oscillating saw and stem lifted out of the cement mantle.The surgeon was able to isolate the anterolateral geniculate artery, and this was cauterized.The previous cement mantle was left in place and a new batch of depuy cement was used to implant a newly opened all-poly tibial component.Blood loss was estimated at 600 ml during the procedure.There is no evidence of blood transfusion nor intervention after cauterization.Doe: (b)(6) 2013.Left 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.

• 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 Key: 10535139
• Report Number: 1818910-2020-20056
• Device Sequence Number: 2793333
• Product Code: JWH
• UDI-Device Identifier: 10603295233565
• UDI-Public: 10603295233565
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2020

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 Expiration Date: 12/31/2017
• Device Model Number: 96-0660
• Device Catalogue Number: 960660
• Device Lot Number: D12121383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC*SIGMA A/P CVD TB 8MM,SZ 5; PFC*SIGMA A/P CVD TB 8MM,SZ 5; PFC*SIGMA C/R NPOR FEM LT SZ6; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; PFC*SIGMA A/P CVD TB 8MM,SZ 5; PFC*SIGMA A/P CVD TB 8MM,SZ 5; PFC*SIGMA C/R NPOR FEM LT SZ6; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 126