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 Codes	Loss of or Failure to Bond (1068); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
Date of Event	02/17/2021
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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since (b)(6) 2015.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.
Event or Problem Description
(b)(4).Clinical adverse event received for flexion instability.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2010.Date of event: (b)(6) 2021.(right knee) medical record review reveals office notes (b)(6) 2021 indicate the patient is experiencing pain, instability, and feelings of her knee ¿clunking¿.Physical exam reveals laxity and flexion instability.The surgeon indicates that the ¿clunk¿ being felt is the tibia subluxing slightly on the femoral component, not related to patella clunk.The database indicated that the knee has now been revised, on (b)(6) 2021, to address instability and aseptic loosening of the femur at an unspecified interface.The femur and tibial insert components were revised--the tibial tray and patella were retained.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : patient product x-ray images have been provided for review.No device associated with this report was received for examination.Provided images are jpeg files within patient medical records.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).Where the lot code was provided, 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11939809
• Report Number: 1818910-2021-11894
• Device Sequence Number: 11818891
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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/OV/DOME PAT 3PEG,38; MBT CEM KEEL TIB TRAY SZ3; PFC SIGMARP CV TB/IN S3 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 132 KG