MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TC3 FEM LEFT SZ2; SIGMA REVISION IMPLANT : KNEE FEMORAL

Model Number	96-0081
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2019
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
We received a user report from (b)(6) for a patient born (b)(6).Fracture of the femoral anchorage stem in revision endoprosthesis.Fracture at the screw anchorage at the transition intramedullary stalk/; femoral component 3 years after implantation.
Additional Manufacturer Narrative
Product complaint (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.  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).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: PFC SIGMA TC3 FEM LEFT SZ2
• 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: 9218510
• Report Number: 1818910-2019-111134
• Device Sequence Number: 19379127
• Product Code: JWH
• UDI-Device Identifier: 10603295232483
• UDI-Public: 10603295232483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/01/2019

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 Expiration Date: 07/31/2022
• Device Model Number: 96-0081
• Device Catalogue Number: 960081
• Device Lot Number: 265148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/23/2019; 11/19/2019; 01/21/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/17/2019; 11/21/2019; 01/27/2020
• 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 OFFSET TIB TRAY LM/RL S3; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC*SIGMA DI AUG16MMCO,SZ2LEFT; PFC*SIGMA DI AUG16MMCO,SZ2LEFT; PFC*SIGMA TC3 INS 30MM, SZ 3; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL FEM SLV DIS POR 34MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR