MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV 20G - EO; BONE CEMENT : BONE CEMENT

Model Number	3122-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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
(b)(4) medical records ad 13 jan 2021 were reviewed.On (b)(6) 2016, the patient had a left knee arthroplasty.Operative notes were not provided, but a sticker sheet with product information was.Depuy components including depuy patella and depuy cement x2 were used during the procedure.On (b)(6) 2019, the patient had a revision to address tibial component loosening.Prior to the revision, the patient was noted to have a large effusion, some laxity throughout range of motion, pain and radiographs were reported to show a small area of osteolysis at the medial tibial plateau.The revision notes provided were minimal and only noted a postoperative diagnosis of tibial component loosening, with no mention of interface, effusion, or osteolysis.Postoperative radiographs from 10/14/2019 note that on the lateral view, there is some radiolucency at the anterior flange of the femur on the lateral view, however, again at the time of surgery this component was noted be very well fixed.The sticker sheet provided show only tibial components, including insert.No mention of patella or femoral component, it would be reasonable to conclude they were not revised.Doi: (b)(6) 2016 dor: (b)(6) 2019 (left knee).
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 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: 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.
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.
Event or Problem Description
On (b)(6) 2019, the patient underwent a left knee revision to address pain, instability, edema, osteolysis, synovitis, and tibial tray loosening at the cement to implant interface.The tibial tray and tibial insert were revised.The femoral component and patella component were retained.The patient was revised with depuy products and cement.There were no indicated intra-operative complications.
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 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 : 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: SMARTSET MV 20G - EO
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11294432
• Report Number: 1818910-2021-02589
• Device Sequence Number: 17014591
• Product Code: LOD
• UDI-Device Identifier: 10603295168362
• UDI-Public: 10603295168362
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 3122-020
• Device Catalogue Number: 3122020
• Device Lot Number: 8069528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 12/16/2021; 02/11/2022
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/25/2021; 01/11/2022; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE PS FEM LT SZ 8 CEM; SMARTSET MV 20G - EO; SMARTSET MV 40G - EO; ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE PS FEM LT SZ 8 CEM; SMARTSET MV 20G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male