MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG C/R POROCOAT FEM LT SZ 4; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	94-0014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Loss of Range of Motion (2032)
Date of Event	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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: dots.Clinical adverse event received for adhesions.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2021, date of event: (b)(6) 2021, (left knee).Treatment: manipulation under anesthesia (b)(6) 2021.
Event or Problem Description
Medical records and operative notes reviewed: on (b)(6) 2021, patient received a primary left total knee arthroplasty to address end-stage osteoarthritis.The patient received j&j sigma press-fit femur and cemented patella and tibial tray components, with cr rp tibial insert articulation.Depuy bone cement was utilized.The procedure had no reported complications.On (b)(6) 2021, patient was treated with a left knee manipulation under anesthesia to address arthrofibrosis.Prior to the procedure, he only had about 95 degrees of flexion, with significant stiffness.Following the manipulation, the patient was able to flex between 115-120 degrees.There were no reported complications.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG C/R POROCOAT FEM LT SZ 4
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12481516
• Report Number: 1818910-2021-20278
• Device Sequence Number: 3821318
• Product Code: MBH
• UDI-Device Identifier: 10603295223405
• UDI-Public: 10603295223405
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K062654
• 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): 08/26/2021

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: 94-0014
• Device Catalogue Number: 940014
• Device Lot Number: J44M58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/19/2021
• 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; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG C/R POROCOAT FEM LT SZ 4; SIG RP AOX CRV INS SZ4 10; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMA/OV/DOME PAT 3PEG,41; SIG C/R POROCOAT FEM LT SZ 4; SIG RP AOX CRV INS SZ4 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 85