MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIG CR NPOR FEM RT SZ 4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	1960-01-400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
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 adverse event received for aseptic loosening of the femoral component: migration/loosening - femoral.Event is serious and is considered moderate.Event is definitely related to device and is definitely not relate to procedure.Date of implantation: (b)(6) 2016.Date of event (onset): (b)(6) 2021 (right knee).On (b)(6) 2016, the patient received a pfc sigma rotating platform knee during a total knee arthroplasty to address osteoarthritis.The patella was resurfaced during the procedure.There were no indicated intra-operative complications.On (b)(6) 2021, the patient presented for a right knee evaluation due to pain, discomfort, swelling, effusion, decreased range of motion, and stiffness.The physician indicated he went back to the original x-ray images and the interface of the femoral component looked pristine.A couple of years ago, there were some mild interface change.Now x-ray images reveal a grossly loose femoral component.The physician aspirated 20 ml of clear, blood-tinged fluid from the knee and sent for culture and gram stain.The physician indicated the patient would need to undergo a revision of the right knee.There is no evidence of a right knee revision within the reviewed medical records.Treatment: awaiting revision surgery.
Event or Problem Description
It was reported that the patient presented for a right knee evaluation due to pain, discomfort, swelling, effusion, decreased range of motion, and stiffness.Treatment: awaiting revision surgery.
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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (patient).
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.

• Brand Name: PFC SIG CR NPOR FEM RT SZ 4N
• 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: 12017127
• Report Number: 1818910-2021-12888
• Device Sequence Number: 4243617
• Product Code: JWH
• UDI-Device Identifier: 10603295074779
• UDI-Public: 10603295074779
• 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: 2016
• 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
• Report Date (Section B): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1960-01-400
• Device Catalogue Number: 196001400
• Device Lot Number: 752729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 07/30/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/02/2021; 07/30/2021
• 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 SZ4; PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 10; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG RP AOX CRV INS SZ4 10
• Patient Age: 64 YR
• Patient Weight: 73