MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER 5 DEGREE; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number 96-0781

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Fever (1858); Unspecified Infection (1930); Itching Sensation (1943); Pain (1994); Sepsis (2067); No Code Available (3191)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received stage 1 of a two-stage revision of the right knee to treat pain, swelling, walking difficulty, and pruritis secondary chronic infection progressing to severe sepsis.Upon entering the joint, the surgeon encounters and removed gross purulence from the joint.Significant synovitis and infected tissue were debrided.All components were explanted and replaced with depuy products and competitor cement x 5, and stimulan antibiotic beads.The patient was implanted with depuy products utilizing competitor cement.The procedure was completed without complications.The patient was placed on 6-week iv antibiotics.Stage two revision is scheduled for 6 weeks, pending clearance of infection.Doi: (b)(6) 2016 (patella), doi: (b)(6) 2018 (insert, tibial and femoral components), doe: (b)(6) 2018 (wound debridement), doe: (b)(6) 2019 (decompression), dor: (b)(6) 2019 (insert exchange), doe: (b)(6) 2019 (wound dehiscence repair), dor: (b)(6) 2020 (stage 1 revision), right knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary:no device associated with this report was 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.

• Brand Name: SIGMA FEM ADAPTER 5 DEGREE
• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10247608
• MDR Text Key: 201262032
• Report Number: 1818910-2020-15338
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295233916
• UDI-Public: 10603295233916
• Combination Product (y/n): N
• PMA/PMN Number: K060515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96-0781
• Device Catalogue Number: 960781
• Device Lot Number: HZ0267
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 41 MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 37 MM; PFC SIGMA FEM POST AUG SZ4 4 MM; PFC SIGMA FEM POST AUG SZ4 4 MM; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SYNTHES SCREW BONE (204830); TC3 RP TIBIAL INSERT S4,12.5; UNIVERSAL STEM 115X16 MM FLUTED; UNIVERSAL STEM 75X18 MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 118