MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0092
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	06/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2014, the patient underwent a right knee revision due to instability, synovitis, tibial insert wear, and tibial tray migration and loosening at the cement to implant interface.Unknown manufacturer products were revised.Depuy products were implanted during the revision.It is noted, at the end of the procedure, the surgeon reported an intraoperative distal femoral fracture extending about 10 cm proximally.The fracture was treated with 4 cerclage wires and noted to be stable.On (b)(6) 2019, the patient underwent a right knee revision due to pain, instability, swelling, and infection.The tibial insert was exchanged and the surgeon performed an irrigation and debridement.On (b)(6) 2020, 5-week post-operative visit indicated significant effusion of the left knee with mild erythema but no ovral warmth.After revision, the patient received iv antibiotics via a picc line.The patient's crp were still elevated compared to normal, but were continuing to trend down.This pc captures the intraoperative femur fracture on (b)(6) 2014.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9748783
• Report Number: 1818910-2020-05843
• Device Sequence Number: 19017693
• Product Code: JWH
• UDI-Device Identifier: 10603295232599
• UDI-Public: 10603295232599
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 96-0092
• Device Catalogue Number: 960092
• Device Lot Number: 515696
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR