MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA PLI XLK INS 2.5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-02-112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Fluid Discharge (2686); No Code Available (3191)
Date of Event	08/23/2020
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
It was reported that the patient underwent poly exchange and i&d due to suspected infection in her knee.Doi: (b)(6) 2020, dor : (b)(6) 2020, right knee.
Event or Problem Description
Medical records were received and reviewed: on (b)(6) 2020, the patient underwent a right knee revision of the tibial insert to address an acute infection.The surgeon indicated the knee arthroplasty occurred 3 to 4 weeks prior to this current revision.Antibiotic pellets were also placed.Leading up to the revision the patient was experiencing pain, drainage, inflammation, and instability.The surgeon noted when attempting to complete closure of the wound, there was a small area of about 4 to 5 cm below the tibial plateau that was somewhat deficient.The surgeon over sewed this with subcutaneous tissue.On (b)(6) 2020, the patient presented for a right knee evaluation with drainage and delayed wound healing.The wound was being treated with a wound vac.On (b)(6) 2020, the patient presented for a right knee revaluation with slight drainage and continued use of the wound vac.On (b)(6) 2020, the patient underwent an irrigation and debridement due to delayed wound healing and to complete closure of the wound.No products were revised during the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not 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.H6 patient code: no code available (3191) used to capture the joint instability.

• Brand Name: SIGMA PLI XLK INS 2.5 12.5MM
• 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: 10503387
• Report Number: 1818910-2020-19543
• Device Sequence Number: 3222667
• Product Code: JWH
• UDI-Device Identifier: 10603295062448
• UDI-Public: 10603295062448
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/23/2020

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 Model Number: 1581-02-112
• Device Catalogue Number: 158102112
• Device Lot Number: 8943702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: DEPUY CMW 1 40G; DEPUY CMW 1 40G; PFC*SIGMA C/R NPOR FE RT SZ2.5; SIG MOD TIB TRAY CEM COCR 2.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 77