MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2362
Medical Device Problem Codes	Off-Label Use (1494); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Ecchymosis (1818); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2019
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
On (b)(6) 2019, the patient had a right total knee revision to address pain, discomfort, instability, due to trauma, swelling, and difficulty walking.The patient¿s past surgical history included right knee surgery x4.During this procedure the insert was revised.Depuy component tibial tray with the tip of the post approximately 8mm removed.The real poly was now inserted and the tip of the post of the polyethylene was removed, so it did not impinge in the box" (sticker page 352 of 374).Doi: unk, dor: (b)(6) 2019, affected side: right knee.This complaint was linked to (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided from medical record review indicates "before implantation, the surgeon cut approximately 8 mm off the tibial post in order to make it fit the existing tibial tray keel.There were no patient consequences or adverse events associated with the adulteration and off label use of the newly implanted tibial insert." at this time depuy synthes joint reconstruction considers the device on this report to be not reportable.Further updates will only be provided if additional information is received that changes the regulatory determination.H6.

• Brand Name: TC3 RP TIBIAL INSERT S5,12.5
• Common Device Name: 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, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13154346
• Report Number: 1818910-2022-00102
• Device Sequence Number: 17180355
• Product Code: NJL
• UDI-Device Identifier: 10603295242499
• UDI-Public: 10603295242499
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2362
• Device Catalogue Number: 962362
• Device Lot Number: HY7887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 03/23/2022; 04/19/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/13/2022; 03/29/2022; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 125 KG