MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 2.5 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	10/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).Initial reporter occupation: lawyer.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 underwent joint aspiration of the right knee on (b)(6) 2016: due to swelling and pain.This was done in office.Additionally, on (b)(6) 2016 the patient was seen in the er for pain, swelling and drainage in her right knee.The patient was admitted for suspected knee cellulitis and septic arthritis.Patient also had x-rays performed on that date that were suggestive of prepatellar bursitis with small effusion.While hospitalized, the patient underwent an irrigation and debridement and polyethylene exchange due to confirmed infection of the right knee.Doi: (b)(6) 2015; dor: (b)(6) 2016; dor: (b)(6) 2016 (i&d with poly exchange).
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a duplicate report of 1818910-2016-30728.1818910-2020-00257 is being retracted as it is a report duplication.1818910-2016-30728 will be kept for investigational purposes.

• Brand Name: PFC SIGMARP STB TB IN 2.5 17.5
• 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: 9544842
• Report Number: 1818910-2020-00257
• Device Sequence Number: 11348348
• Product Code: NJL
• UDI-Device Identifier: 10603295241201
• UDI-Public: 10603295241201
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 02/28/2021
• Device Model Number: 96-2124
• Device Catalogue Number: 962124
• Device Lot Number: 8267476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 02/06/2020
• 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 DOME PAT 35MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; PFC SIG FEM POST AUG SZ2.5 4MM; PFC SIG FEM POST AUG SZ2.5 8MM; PFC*SIGMA DIS AUG4MM,S2.5,RGHT; PFC*SIGMA TC3 FEM RT SZ2.5; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL STEM 75X14MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 95