MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI XLK INS 2.5 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-02-115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Fluid Discharge (2686); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Clinical adverse event received for recurrent drainage from incisional area : infection on (b)(6) 2021, the patient presented for a clinic visit for an evaluation due to right knee drainage and edema.Cultures revealed staphylococcus epidermidis and candida.On (b)(6) 2021, the patient underwent a right knee revision to address wound drainage, recurrent infection, and edema.The post-operative diagnosis was indicated as recurrent infection while the "findings" section of intra-op note described the infection as chronic.The surgeon noted there was an erosion of the middle portion of the extensor mechanism just at the level of the joint line.(it is indicated the patient previously underwent an extensor mechanism reconstruction in (b)(6) 2020 to address a ruptured extensor mechanism.Captured on (b)(4).) the surgeon also noted removal of necrotic-appearing tissue.All components were removed and were replaced with a sure space femoral spacer and sure space tibial spacer.Two grams of vancomycin and 100 mg of amphotericin were used per batch of cement.Two batches of depuy 2 with gentamicin cement was utilized.The surgeon indicated the patient would be on iv antibiotics post-operatively.There were no indicated intra-operative complications.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2021.Date of revision: (b)(6) 2021 (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.Should additional information be received, the information will be reviewed and the investigation may 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA PLI XLK INS 2.5 15MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12121164
• Report Number: 1818910-2021-14315
• Device Sequence Number: 11704398
• Product Code: JWH
• UDI-Device Identifier: 10603295062455
• UDI-Public: 10603295062455
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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 Model Number: 1581-02-115
• Device Catalogue Number: 158102115
• Device Lot Number: 8586299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FE RT SZ2.5; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 15MM; DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FE RT SZ2.5; SIG MOD TIB TRAY CEM COCR 2.5; SIGMA PLI XLK INS 2.5 15MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 93