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 Codes	Loss of or Failure to Bond (1068); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/08/2018
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
Voluntary report was received under mw5098568.Patient contacted and indicates she was experiencing pain, loosening, popping, instability and swelling which lead to a revision.Doi: (b)(6) 2012, dor: (b)(6) 2018, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not 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).Where the lot code was provided, 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: 11266508
• Report Number: 1818910-2021-02268
• Device Sequence Number: 3374334
• Product Code: JWH
• UDI-Device Identifier: 10603295074779
• UDI-Public: 10603295074779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 1960-01-400
• Device Catalogue Number: 196001400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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: PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV DOME PAT 3 PEG,32; UNK KNEE TIBIAL INSERT SIGMA; UNK KNEE TIBIAL TRAY SIGMA; UNKNOWN BONE CEMENT (40G); PFC SIG CR NPOR FEM RT SZ 4N; PFC*SIGMA/OV DOME PAT 3 PEG,32; UNK KNEE TIBIAL INSERT SIGMA; UNK KNEE TIBIAL TRAY SIGMA; UNKNOWN BONE CEMENT (40G)
• Outcome Attributed to Adverse Event: Required Intervention