MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2.5 10; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-021
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for increasing pain and swelling.Event is not serious and is considered mild.Event is possibly related to device and definitely not related to procedure.Doi: (b)(6) 2012; doe: unk (right knee aspirations); dor: (b)(6) 2021; (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).This device was also reported on (b)(4) as the patient experienced adverse events on different days with the same device.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) 2021.Patient received bilateral pfc sigma tkas to treat pain disability secondary to end-stage patellofemoral disease.Both patellas were resurfaced and unknown cement was utilized.The procedure was completed without complications.The patient received an unspecified number of right knee joint aspirations to treat pain and swelling.Clinic visit dated (b)(6) 2021: patient presents with progressive right knee pain, stiffness, and swelling.Physical examination confirms significant right knee warmth and swelling with 1-2 mm varus/valgus laxity.X-rays identify a stable left knee and right knee with femoral, tibial, and patellar lucency.Patient is referred for revision of the right knee.Also, another additional information received confirmed that there were 3 joint aspirations 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.H10 additional narrative: the device was also reported on (b)(4) as the patient experienced adverse events on different days with the same device.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIG RP AOX CRV INS SZ2.5 10
• 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: 13282880
• Report Number: 1818910-2022-01109
• Device Sequence Number: 4978676
• Product Code: NJL
• UDI-Device Identifier: 10603295076124
• UDI-Public: 10603295076124
• 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: 2012
• 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): 01/18/2022

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: 1961-92-021
• Device Catalogue Number: 196192021
• Device Lot Number: 3463100
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 01/06/2022; 02/04/2022; 02/14/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 01/28/2022; 02/08/2022; 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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: MBT CEM KEEL TIB TRAY SZ2.5.; PFC*SIGMA C/R NPOR FE RT SZ2.5.; PFC*SIGMA/OV/DOME PAT 3PEG,38.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 79 KG