MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 5 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-15-112
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent a right medial unicompartmental knee replacement many years ago (not a depuy implant).A number of years later the patient presented with a broken tibial component.At this time in 2015, the unicompartmental knee replacement was revised to a primary pfc femoral component with a stemmed tibial component (depuy cement was not utilised).The medial side of the tibia was bone grafted with an autograft and held in place with two k wires.Approximately 3 years after this "revision" the patient reports having been hit/ rammed by a cow and experienced some form of trauma around the medial aspect of the right knee.Patient has had progressively increasing pain, very specifically around the medial epicondyle of the femur.A decision was made to open the knee and investigate the cause and to look to change the bearing.On opening the knee, the synovial fluid was found to be blood stained.There also appeared to be traces of blackened metalosis (this has been attributed to the original uni knee which had broken as no metal on metal articulation was evident) a boney spur was evident around the medial epicondyle and there appeared to be wear to the poly bearing in the areas where this "spur" may have come into contact with the poly.The knee appeared to be a little lax in flexion vs extension.The boney spur was removed, the wound washed out and a slightly thicker insert implanted (from a 12.5mm cr curved to a 15mm cr curved plus insert) the knee appeared stable.Doi: unk 1st dor: 2015, 2nd dor: feb 18, 2022, right knee.
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: device associated with this report was not received for examination.All available x-rays and photographs 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.
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.

• Brand Name: SIGMA CRVD XLK INS 5 12.5MM
• 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: 13684375
• Report Number: 1818910-2022-04136
• Device Sequence Number: 12023413
• Product Code: JWH
• UDI-Device Identifier: 10603295063650
• UDI-Public: 10603295063650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2022

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: 1581-15-112
• Device Catalogue Number: 158115112
• Device Lot Number: 8025545
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 05/13/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 05/10/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2014
• 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/OV/DOME PAT 3PEG,41; SIG C/R POROCOAT FEM RT SZ 5; SIG MOD TIB TRAY CEM COCR 5; SIGMA CRVD XLK INS 5 12.5MM; UNIVERSAL STEM 115X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male