MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-13-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Update ad 16 nov 2020: review of medical records from related complaint ((b)(4)): update: medical records received ad 16 nov 2020 were reviewed on 20 nov 2020 by a clinician to identify patient harms/product issues.Primary operative notes (b)(6) 2008 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The surgery was completed without indication of complication by the surgeon.Revision notes (b)(6) 2010 indicate the patient received a left total knee revision of the tibial insert due to tibial soft tissue abscess and chronic left total knee joint infection, swelling and pain.Upon entering the knee joint, cloudy fluid and abnormal fibrous tissue was encountered and removed.The insert was revised and a drain was placed.Procedure notes (b)(6) 2018 indicate the patient received and irrigation and debridement with placement of a wound vac and antibiotic beads due to a peri-articular infected cyst, pain and swelling of the lower left leg.It is indicated by the surgeon that there is no connection or communication to the knee joint.No products were revised, the knee joint was not entered.Office notes (b)(6) 2020 indicate the patient is being seen due to recent pain and swelling below her gastroc flap of her left knee.A sterile aspiration was performed and reveals around 7ccs of gross puss.It is indicated the surgeon does not believe this abscess involves the knee joint.Radiographs reveal slight lucencies around the femoral component.Procedure notes (b)(6) 2020 indicate the patient received an irrigation and debridement of her lower gastroc flap abscess.It is indicated in the procedure notes that pus and fatty necrotic tissue was expressed and there did not appear to be any track to the knee joint.This was irrigated fully.A drain was placed, and the incision was closed without complication.No products were revised, the knee joint was not entered.
Event or Problem Description
On (b)(6) 2010, the patient had a revision, irrigation and debridement left proximal tibial abscess due to proximal tibial soft tissue abscess and probable chronic infection left total knee arthroplasty.The indications for surgery noted that the patient had pain, increased swelling, and stiffness.The surgeon reported finding inflammation.No components were revised.On (b)(6) 2018, the patient had an incision and drainage with debridement periarticular/extracapsular infected cyst, left knee arthroplasty due to periarticular infected cyst, left knee.The indications for surgery included a history of chronic left knee infection.The surgeon reported finding the extra articular cyst to be infected, with no communication with the knee joint.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.However x-rays were provided.Upon visual inspection of the x-rays, 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.

• Brand Name: SIGMA CRVD XLK INS 3 10MM
• 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; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 10942230
• Report Number: 1818910-2020-26097
• Device Sequence Number: 14205062
• Product Code: JWH
• UDI-Device Identifier: 10603295063391
• UDI-Public: 10603295063391
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• 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): 11/16/2020

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: 1581-13-110
• Device Catalogue Number: 158113110
• Device Lot Number: 2782234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 03/16/2021; 02/14/2022; 03/08/2022
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 03/31/2021; 02/21/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2008
• 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: PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG MOD TIB TRAY CEM COCR 3; SIGMA CRVD XLK INS 3 10MM; PFC*SIGMA C/R NPOR FEM LT SZ 3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA CRVD XLK INS 3 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White