MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4N L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-40-450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Medical records received ad 23 jul 2021.Patient had a unknown depuy sigma system implanted.On (b)(6) 2019, the patient underwent a primary left knee arthroplasty to address osteoarthritis.Depuy products were implanted, patella was resurfaced, and unknown cement was utilized.There were no indicated intra-operative complications.On (b)(6) 2019, the patient underwent a left knee revision to address infection.At evaluation visits prior to revision, the patient was experiencing pain, swelling, and decreased range of motion.The surgeon noted synovitis, softening of the bone, and a small abscess in the patella that was debrided.The tibial insert, tibial tray, and femoral component were revised.There is no evidence the patellar component was revised.The surgeon placed an antibiotic spacer and the patient received iv antibiotics.There were no indicated intra-operative complications.Doi: (b)(6) 2019; dor: (b)(6) 2019; left knee.
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.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: SIGMA PS CEM FEM SZ4N L
• 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: 12336155
• Report Number: 1818910-2021-18056
• Device Sequence Number: 19539461
• Product Code: JWH
• UDI-Device Identifier: 10603295075066
• UDI-Public: 10603295075066
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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 Expiration Date: 08/31/2026
• Device Model Number: 1960-40-450
• Device Catalogue Number: 196040450
• Device Lot Number: C81052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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: PFC*SIGMA/RD/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 3; SIGMA PS CEM FEM SZ4N L; SIGMA STAB XLK INS 3 8MM; PFC*SIGMA/RD/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 3; SIGMA PS CEM FEM SZ4N L; SIGMA STAB XLK INS 3 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR