MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-053
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Chills (2191); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
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
(b)(6).Clinical adverse event received for acute hematogenous sepsis - deep infection.Event is serious and is considered moderate.Event is possibly related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2021, (left knee).Treatment: revision of tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.Reviewing the x-rays provided on the attachments we can not confirm the reported event.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.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.
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.Corrected: h6 (medical device problem code).
Event or Problem Description
On (b)(6) 2018, the patient had a left cemented total knee arthroplasty to address primary osteoarthritis end-stage left knee.Depuy components including depuy patella was used during this procedure.There were no complications noted.On (b)(6) 2021, the patient had a revision left total knee arthroplasty, tibial component to address acute hematogenous sepsis.The patient has had erythema, swelling, pain, fever and chills.Prior to surgery, gross puss was aspirated from the knee.During the procedure, the surgeon observed gross puss.The surgeon also noted that the polyethylene insert had really minimal wear.All components were noted to have been well fixed.Only the insert was revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: SIG RP AOX CRV INS SZ5 15
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12646832
• Report Number: 1818910-2021-22863
• Device Sequence Number: 1713109
• Product Code: NJL
• UDI-Device Identifier: 10603295076261
• UDI-Public: 10603295076261
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1961-92-053
• Device Catalogue Number: 196192053
• Device Lot Number: 9700354
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 11/29/2021; 01/03/2023
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/30/2021; 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 3 40G.; MBT CEM KEEL TIB TRAY SZ5.; PFC*SIGMA C/R NPOR FEM LT SZ5.; PFC*SIGMA/OV/DOME PAT 3PEG,41.; SIG RP AOX CRV INS SZ5 15.; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ5 15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 107 KG