MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FE RT SZ2.5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0018
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); Fibrosis (3167); Swelling/ Edema (4577)
Date of Event	03/24/2021
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: dots.Clinical adverse event received for loosening of femoral component - abnormal radiographic evaluation : osteolysis zone 1 and 4 of femur and tibia, loosening of the femoral component.Event is serious and is considered severe.Event is possibly related to device and there is a remote possibility that it is related to procedure.Date of implantation: (b)(6) 2017.Date of event (onset): (b)(6) 2021.(right knee).Treatment: currently none - awaiting knee revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2021, the patient's right knee was revised to address aseptic loosening of the femur and tibial tray components, along with arthrofibrosis.Femur, tibial tray, and tibial insert components were revised, and depuy attune revision components re-implanted to treat.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• 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: 11804544
• Report Number: 1818910-2021-09943
• Device Sequence Number: 3480991
• Product Code: JWH
• UDI-Device Identifier: 10603295232070
• UDI-Public: 10603295232070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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,Followup,Followup
• Report Date (Section B): 04/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0018
• Device Catalogue Number: 960018
• Device Lot Number: D16061045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 06/29/2021; 09/01/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/02/2021; 07/21/2021; 09/01/2021
• 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 3 40G.; DEPUY CMW 3 40G.; MBT CEM KEEL TIB TRAY SZ2.5.; PFC*SIGMA/OV/DOME PAT 3PEG,35.; SIG RP AOX CRV INS SZ2.5 12.5.; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG RP AOX CRV INS SZ2.5 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 74