MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PS CEM FEM SZ4N R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196050450
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
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
The patient was revised to address loosening of the femoral and tibial components at the cement to implant interface.Cement manufacturer is unknown.It was also reported that the femur and tibia were found to "fell out of the patient".Revised to a sigma tc3 mbt construct.Patella was not revised.No further patient information available.Doi: 2014.Dor: (b)(6) 2019; right knee.
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.Product complaint # (b)(4).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 will be filed as appropriate.

• Brand Name: SIGMA PS CEM FEM SZ4N R
• 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: 9250237
• Report Number: 1818910-2019-112841
• Device Sequence Number: 1864263
• Product Code: JWH
• UDI-Device Identifier: 10603295075158
• UDI-Public: 10603295075158
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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 Catalogue Number: 196050450
• Device Lot Number: 467528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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 SIGMARP STB TB IN 4 12.5; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR