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	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	10/04/2021
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
Subject id: (b)(6).Study: dots.(b)(6).Clinical adverse event received for possible infection as well as bone resorptive changes.Event is serious and is considered moderate.Event is probably 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: pt had a washout of his native ankle for sepsis, no further treatment with antibiiotics.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
It was reported that the patient has had a revision of left total knee as treatment to address aseptic loosening of the tibial tray.The loosening was identified during the interim pre-op evaluation.Doi (b)(6) 2018: patient received a left knee primary sigma tka to treat primary end-stage oa with varus disease.The patella was resurfaced and depuy cement x 3 was utilized.The procedure was completed without complications.Clinic note dated (b)(6) 2021: patient reports intermittent swelling, pain, and loss of range of motion in the left knee over the last year.Physical exam confirms swelling and warmth, as well as a reduction in left knee extension.X-rays indicate stress shielding around the left tibial component, which is progressive from last film dated 2018.Surgeon performs an aspiration of 70 ccs from the left knee to relieve the pressure and sends the fluid in for a synovasure test to determine if there is infection present.Of note: the patient has not been seen for quite some time for his knee due to multiple spinal surgeries.All radiographic images were compared with the last films done around the time of the primary tka in 2018.Phone call dated (b)(6) 2021: synovasure results are negative for infection.Patient reports some relief from the aspiration but is still having swelling and pain.Patient is referred for ct scan.Phone call dated (b)(6) 2021: ct scan results indicate tibial tray loosening and osteolysis around the femoral component.Patient is referred for a left knee revision.Dor dated (b)(6) 2022: patient received a left knee revision to treat pain, swelling, and loss of range of motion secondary to tibial tray loosening.Upon entering the joint, the surgeon evacuates a large effusion.The surgeon confirms that the extensor mechanism is very tight.The surgeon identifies and debrides scar tissue and abundant synovitis secondary to cement-debris wear caused by the loosening and debonding of the tibial tray at the cement to implant interface.The tibial tray was revised, and the cement was removed without reported bone loss.The femoral component was well-fixed but revised due to extensive osteolysis around the device.There was no product problem with the revised tibial insert.The patella was well-fixed and retained.The patient was revised with attune revision products utilizing depuy cement.The procedure was completed without complications.Doi:(b)(6) 2018.Doe: (b)(6) 2021: aspiration of left knee to treat swelling.Dor: (b)(6) 2022: continuation of treatment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary:no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.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).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: b5, b7, d6b, h6 (clinical and impact codes).

• 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
• 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: 12673713
• Report Number: 1818910-2021-23148
• Device Sequence Number: 19953370
• 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: 2018
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 10/04/2021

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: 8688401
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 02/03/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/29/2021; 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC*SIGMA C/R NPOR FEM LT SZ 4; PFC*SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ4 12.5; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT CEM KEEL TIB TRAY SZ4; PFC SIGMA C/R NPOR FEM LT SZ 4; PFC SIGMA/OV/DOME PAT 3PEG,41; SIG RP AOX CRV INS SZ4 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White