MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Pain (1994); Synovitis (2094); Discomfort (2330); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2021
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 heterotopic bone in suprapatellar pouch : pain, severe.Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2021, (right knee).Treatment: arthrotomy with ostectomy of heterotopic bone.
Event or Problem Description
On (b)(6) 2020, the patient underwent bilateral primary knee arthroplasty to address osteoarthritis.Depuy products and cement were utilized in both knees.There were no indicated intra-operative complications.On (b)(6) 2021, the patient presented for a bilateral knee evaluation.In the right knee, the patient was experiencing pain, discomfort, swelling, and a palpable pop when going from flexion to extension.On (b)(6) 2021, the patient underwent a right knee arthrotomy with ostectomy of heterotopic bone of dorsal femur.The surgeon noted a significant amount of crepitus under the extensor mechanism of the right knee.The surgeon also noted excising moderate hypertrophic synovitis.No products were revised.There were no indicated intra-operative complications.On (b)(6) 2021, the patient presented for a post-operative evaluation of the right knee.The patient was noted to be doing very well with no issues.
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.H6 clinical code: appropriate term / code not available (e2402) is used to capture musculoskeletal system (e16).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 clinical code: removed code for appropriate term/ code not available (e2402) which captures heterotropic ossification and replaced with calcification (e230901).
Additional Manufacturer Narrative
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: added: h6.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected g3 awareness date of follow up # 1 to (b)(6) 2021 since it was reported in error.
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: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: SIG RP AOX CRV INS SZ4 12.5
• 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: 11516701
• Report Number: 1818910-2021-05451
• Device Sequence Number: 11743743
• Product Code: NJL
• UDI-Device Identifier: 10603295076216
• UDI-Public: 10603295076216
• 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: 2020
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/05/2021

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: 1961-92-042
• Device Catalogue Number: 196192042
• Device Lot Number: 9043378
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 03/11/2021; 03/22/2021; 05/03/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 03/30/2021; 04/05/2021; 04/06/2021; 05/03/2021
• 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 2 20G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM RT SZ 4; SIG RP AOX CRV INS SZ4 12.5; DEPUY CMW 2 20G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG C/R POROCOAT FEM RT SZ 4; SIG RP AOX CRV INS SZ4 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95