MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA TC3 FEM RT SZ2.5; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	960092
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	04/16/2019
Type of Reportable Event	Malfunction
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
It was reported that while assembling the revision component (parts listed below) the lateral posterior augment combo failed to screw/lock into the femoral tc3 component.After multiple attempts by 2 experienced people, a second augment was opened; this augment also failed to lock into the femoral component.With both pieces, when they attempted to torque the screw with the torque wrench, the augments lifted away from the femur.Distal augments were placed prior to the attempted placement of the posterior augments as is customary.The conclusion was that the threads in the femoral component were not right.One of the posterior augments was subsequently cemented onto the femur and the entire component was cemented into the patient.All other augments 3 additional were assembled in the normal fashion.The stem also went on with no issues.There was a surgical delay of 15 minutes.
Additional Manufacturer Narrative
B)(4).Investigation summary = > the device associated with this reported event was not returned 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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8592701
• Report Number: 1818910-2019-92923
• Device Sequence Number: 2010728
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 960092
• Device Lot Number: J1368J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 79