MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA INSET PAT 25MM; SIGMA KNEE PRIMARY : KNEE PATELLA

Model Number	96-0120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent primary patella femoral joint replacement in (b)(6) 2015.((b)(6) hospital) patient has complained that this pf joint has never felt good and has been painful since time index surgery.A decision was made to revise the pf joint to a total knee replacement.On opening the knee, the femoral component was found to be loose.Progression on disease was also found in the other condyles.The femoral component as well as the insert patella component was removed and a total joint i planted.((b)(6) hospital, (b)(6) 2022).Depuy cement was not utilised.The femoral component was loose at the cement bone interface with the component coming loose with the cement still adhered to the underside.Doi: (b)(6) 2015.Dor: (b)(6), 2022.Unknown knee.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this complaint was received for examination.Photo investigation cannot confirm the reported allegation.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.H10 additional narrative:.

• Brand Name: PFC SIGMA INSET PAT 25MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13498071
• Report Number: 1818910-2022-02570
• Device Sequence Number: 3895434
• Product Code: JWH
• UDI-Device Identifier: 10603295232742
• UDI-Public: 10603295232742
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 96-0120
• Device Catalogue Number: 960120
• Device Lot Number: D14042040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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: PFC SIGMA INSET PAT 25MM; SIGMA HP TROCHLEA SZ1 LT; UNK BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female