MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,17.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962344
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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.
Event or Problem Description
It was reported that surgeon implanted a ps femur and tc3 insert.Discovered the incompatibility issue post op day one.Contacted the surgeon immediately after it was discovered.He was not concerned because of how the implants felt during trialing.Brought the exact size dni's of the femur and tc3 insert to show surgeon two days post op.Surgeon expressed he is not concerned and elected to take no action at this time.

• Brand Name: TC3 RP TIBIAL INSERT S3,17.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8249838
• Report Number: 1818910-2019-81003
• Device Sequence Number: 16626615
• Product Code: NJL
• UDI-Device Identifier: 10603295242253
• UDI-Public: 10603295242253
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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
• Report Date (Section B): 12/19/2018

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: 962344
• Device Lot Number: H20800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Patient Sequence Number: 1
• Patient Age: 72 YR