MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ3 L; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-40-300
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); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	01/14/2021
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
Clinical notification received for revision of left total knee to address aseptic loosening.Date of implantation: (b)(6) 2015, date of revision: (b)(6) 2021, (left knee).Treatment: femur, tibial tray, and insert were revised.On (b)(6) 2015, the patient had a left total knee arthroplasty to address severe degenerative arthritis, and chronic quadriceps tendon dysfunction.On (b)(6) 2021, the patient had a revision left total knee arthroplasty to address pain and failed left total knee arthroplasty due to aseptic loosening.Preoperatively the patient was noted to have experienced pain, instability, and difficulty with ambulation, the operative findings included: grossly loose femur at the cement/bone interface.The tibial tray was loose at the implant/cement interface.The tibial tray had drifted into significant varus and there was significant synovium.There was a large cystic area noted in the tibia.The tibial tray, insert, and femoral components were revised.The patient did not have a patella.Doi: (b)(6) 2015, dor: (b)(6) 2021 (left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA PS CEM FEM SZ3 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: 11436202
• Report Number: 1818910-2021-04581
• Device Sequence Number: 4076331
• Product Code: JWH
• UDI-Device Identifier: 10603295075042
• UDI-Public: 10603295075042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted 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): 02/05/2021

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 Expiration Date: 01/31/2025
• Device Model Number: 1960-40-300
• Device Catalogue Number: 196040300
• Device Lot Number: 8068276
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: BIOMET COBALT MV WITH GENTAMICIN BONE CEMENT; BIOMET COBALT MV WITH GENTAMICIN BONE CEMENT; MBT CEM KEEL TIB TRAY SZ2.5; PFC SIGMARP STB TB IN 3 10.0; SIGMA PS CEM FEM SZ3 L
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 79