MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-052
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Synovitis (2094); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Swelling/ Edema (4577)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical notification received for revision due to instability and hemarthrosis.Date of implant: (b)(6) 2016.Date of revision: (b)(6) /2022.(left knee).Treatment: revision of the tibial insert.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this complaint was received for examination.The photo investigation found nothing indicative of a device nonconformance, from the x-rays provided the reported allegation cannot be confirmed.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
Operative notes were reviewed indicating that on (b)(6) 2016, the patient had a left cement total knee arthroplasty to address primary osteoarthritis endstage left knee with severe varus deformity and medical tibial bone loss.Depuy components were implanted during this procedure, including depuy patella.On (b)(6) 2022, the patient had a revision left total knee arthroplasty, tibial component, ostectomy, multiple osteophytes, to address recurrent hemarthrosis.The indications for surgery include recurrent effusions.During the procedure the surgeon reported finding evidence for chronic bleeding, prominent osteophytes, mild synovitis.There was a little bit of third body debris wear on top side of insert.The patella did not show any wear.
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: added: b1 (is product problem), b5 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (device code).

• Brand Name: SIG RP AOX CRV INS SZ5 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 ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13978301
• Report Number: 1818910-2022-05979
• Device Sequence Number: 6031569
• Product Code: NJL
• UDI-Device Identifier: 10603295076254
• UDI-Public: 10603295076254
• 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: 2016
• 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): 04/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1961-92-052
• Device Catalogue Number: 196192052
• Device Lot Number: 8160262
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 04/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/18/2022; 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY SZ 5; MBT STEP WEDGE SZ5 5MM; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White