MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # : (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
Subject id: (b)(6).Study: (b)(4).Clinical adverse event received for right knee rupture of patellar tendon event not serious and is considered severe event is definitely not related to device and there is a remote possibility it is related to procedure.Date of implantation: (b)(6) 2021.Date of event (onset): (b)(6) 2021.(right knee).Treatment: awaiting surgical intervention.Medical records received were reviewed to identify patient harms/product issues.On (b)(6) 2021, the patient underwent a primary right knee arthroplasty due to osteoarthritis with severe varus deformity.Depuy pfc sigma rotating platform knee was implanted with depuy cement.There were no indicated intra-operative complications.On (b)(6) 2021, the patient underwent a right knee revision to address pain, swelling, effusion, difficulty walking, bruising, instability, with bleeding and ecchymosis developing.It was indicated two days prior, the patient was going down a ladder and missed the rung with his left foot, causing a hyperflexion episode to the right knee and resulting in an acute patellar tendon disruption.The surgeon noted the absence of the patellar tendon and his kneecap was in the patellar alta position.There was noted to be around 200 or 300 ml of blood in the prepatellar space in the joint which was dissected.The surgeon was able to repair the tendon with drill holes through the patella that provided a secure repair with sutures.Cerclage wires were not needed.No products were revised.There were in indicated intra-operative complications.

• Brand Name: SIG RP AOX CRV INS SZ5 12.5
• 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: 11871039
• Report Number: 1818910-2021-10990
• Device Sequence Number: 13683540
• Product Code: NJL
• UDI-Device Identifier: 10603295076254
• UDI-Public: 10603295076254
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 1961-92-052
• Device Catalogue Number: 196192052
• Device Lot Number: 9677233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG C/R POROCOAT FEM RT SZ 5; DEPUY CMW 2 20G; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG C/R POROCOAT FEM RT SZ 5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 117