MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S2,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number 96-2322

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/08/2022

Event Type  Injury  

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.

Event Description

It was reported that total knee explant was performed due to knee joint infection.No additional information.Doi: (b)(6) 2014.Dor: (b)(6) 2014.Affected side : left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S2,12.5
• Type of Device: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15983805
• MDR Text Key: 305490036
• Report Number: 1818910-2022-25448
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295242055
• UDI-Public: 10603295242055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 96-2322
• Device Catalogue Number: 962322
• Device Lot Number: 194971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA FEM POST AUG SZ2 4MM; PFC SIGMA TC3 FEM LEFT SZ2; PFC*SIGMA DIS AUG 4MM,SZ2,LEFT; PFC*SIGMA DIS AUG 4MM,SZ2,LEFT; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S2,12.5; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED; UNK CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 75 KG