MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA MOD TIB TRAY CEM SZ2; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-op infection.This case is from the health authority.It was reported that the patient underwent right knee arthroplasty.During the operation, an anterior median incision of the right knee was selected, about 10 cm in length, the skin and subcutaneous tissue were incised, and then dissociated bilaterally along the deep subfascial space to expose the anterior knee joint and the rectus femoris tendon.Incision of the suprapatellar bursa and articular capsule along the medial side of the rectus femoris tendon, the medial border of the patella to the medial tibial tubercle, turn the patella laterally.Resection of osteophytes, synovium, infrapatellar fat pad, medial and lateral meniscus, anterior and posterior cruciate ligament; distal femoral osteotomy was performed by intramedullary localization, valgus 7 degree osteotomy.Tibial plateau osteotomy was performed by extramedullary localization.Vertical rods were parallel to the long axis of tibia when viewed in anteroposterior and lateral position.The initial thickness of osteotomy was 10 mm, and the osteotomy plane was kept at 3 degree retroversion.After osteotomy, the balance of the extension gap was tested.The 10 mm gap block was used to test the good extension gap.The distal femur was rotated for 3 degrees for quadrilateral osteotomy.The distal femur, anterior condylar, posterior and anteroposterior oblique osteotomy were performed sequentially.After osteotomy, the balance of flexion-extension gap was measured, the flexion-extension tension of knee joint was adjusted, and the superficial and deep layers of medial soft tissue and medial collateral ligament were loosened to ensure the balance of soft tissue in the internal and external space.After cleaning the bone fragments with high pressure pulse irrigator, the no.3 femoral prosthesis and the no.2 tibial prosthesis were fixed with bone cement, and a 10 mm spacer was installed.Reduction and examination of knee joint flexion and extension is good, irrigation of the wound cavity, patella movement track is good, resection of the patella edge hyperosteogeny, electrocautery peripheral edge.Rinsed with saline.The mixture of "ropivacaine + betamethasone" was injected around the knee joint for analgesia, the joint cavity was washed, and the tourniquet was loosened for hemostasis.The surgery was completed.After the surgery, the patient suffered from wound infection.Secondary debridement and suture were given to the patient.No additional information could be provided.
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.

• Brand Name: PFC SIGMA MOD TIB TRAY CEM SZ2
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12868764
• Report Number: 1818910-2021-26283
• Device Sequence Number: 3707788
• Product Code: JWH
• UDI-Device Identifier: 10603295216773
• UDI-Public: 10603295216773
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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 Number: 86-6022
• Device Catalogue Number: 866022
• Device Lot Number: 9726570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC SIGMA MOD TIB TRAY CEM SZ2; UNK KNEE TIBIAL INSERT SIGMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female