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

Model Number	96-2344
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Date of Event	03/09/2020
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 due to the insert was undersized.A size 4 insert should have been used to match the femoral component, not a size 3 to match the tibial tray.Culture showed positive for consistent inflammation.No loosening reported.Doi: (b)(6) 2017; dor: (b)(6) 2020; left knee.
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.The initial reporting stated "the patient was revised due to the insert was undersized.A size 4 insert should have been used to match the femoral component, not a size 3 to match the tibial tray." per the sigma revision surgical technique, a rp insert must match the femur size for size.Therefore, off label use is confirmed for this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.The device associated with this report underwent off label usage.A worldwide complaint database search was performed.A worldwide complaint database search found no additional previously related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.No product contribution to the reported event was identified.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.

• 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: 9881055
• Report Number: 1818910-2020-09271
• Device Sequence Number: 13584526
• Product Code: NJL
• UDI-Device Identifier: 10603295242253
• UDI-Public: 10603295242253
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2344
• Device Catalogue Number: 962344
• Device Lot Number: 460854
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: MBT REVISION CEM TIB TRAY SZ 4; PFC SIGMA TC3 FEM COMP LFT SZ3; TC3 RP TIBIAL INSERT S3,17.5
• Outcome Attributed to Adverse Event: Required Intervention