MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S4,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Edema (1820); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
Patient received a right knee i & d with insert exchange to treat postoperative infection.Upon entering the joint, the surgeon identified and extracted abundant periarticular pus.The surgeon confirmed gross infection of the joint space.The insert was without defect and exchanged for a like tc3 insert.Periarticular infected tissue was excised, and gentle debridement performed with methylene blue and thorough irrigation with saline.Tissue and pus were sent for culture.The surgeon believes this infection is a result of the bone decompression performed on (b)(6) 2019 as there was no infection present in that case.The procedure was completed without complications.Postoperative pathology confirmed a deep infection of (b)(6).Patient was prescribed iv antibiotics for 6 weeks and long-term oral antibiotic therapy.Patient received a right surgical repair of a postoperative superficial wound dehiscence.Upon entering the joint, the surgeon identified and excised all friable tissue and a mucous like membrane from the capsule.The deep capsular repair had partially dehisced and was repaired with competitor suture.The surgeon performed a thorough antibiotic wash-out.There were no product defects and no revisions were performed.The procedure was completed without complications.Right 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: TC3 RP TIBIAL INSERT S4,12.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10254402
• Report Number: 1818910-2020-15470
• Device Sequence Number: 13581967
• Product Code: NJL
• UDI-Device Identifier: 10603295242352
• UDI-Public: 10603295242352
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 96-2352
• Device Catalogue Number: 962352
• Device Lot Number: HG4015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/17/2020
• 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: ATTUNE MEDIAL ANAT PAT 41MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 37MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA TC3 FEM RT SZ4; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SYNTHES SCREW BONE (204830); UNIVERSAL STEM 115X16MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 118