MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 3; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0013
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/15/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Clinical adverse event received for right knee extensor instability : ligament rupture - subluxation of the patella with disrupted medial retinaculum (slight) event is serious and is considered moderate event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2010, date of event (onset): (b)(6) 2010, (right knee).Revision operative notes (b)(6) 2021 indicate the patient received a right total knee revision due to pain, instability, and feelings of popping and clicking.Upon entering the joint, clear fluid, significant synovitis and pieces of polyethylene were encountered.The tibial poly was determined to be fractured and worn with signs of recurrent subluxation / spin-out.The femoral component was noted to have micromotion and signs of early loosening and thus was revised.The tibial component was also revised without indication of deficiency.The patella was left insitu.The surgery was completed without indication of complication by the surgeon.Treatment: none.
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: 12301889
• Report Number: 1818910-2021-17519
• Device Sequence Number: 3807581
• Product Code: JWH
• UDI-Device Identifier: 10603295232025
• UDI-Public: 10603295232025
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 07/12/2021

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: 96-0013
• Device Catalogue Number: 960013
• Device Lot Number: 3117870
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/09/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S3 12.5; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S3 12.5; PFC*SIGMA C/R NPOR FEM RT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 132