MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Edema (1820); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Swelling (2091); Synovitis (2094); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received 23 jul 2018.Medical records were reviewed for mdr reportability.Patient underwent a right tka with depuy cement.She then underwent a closed manipulation for decreased range of motion.Patient was then revised for ongoing pain and swelling.Intraoperative findings included synovitis, scarring, loose tibial component at implant-cement interface, tibial subsidence medially, a small fracture along the anterior tibia with no indication of cause, and a small proximal tibia metaphyseal cyst.Doi: (b)(6) 2015.Dor: (b)(6) 2017.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #
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> (b)(4).Investigation summary
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> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot
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> device history reviewed: no non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 2 additional reports related to implant loosening, and 3 unrelated reports.Total for lot number: 5 (b)(4).Complaints received by cmw in the last 12 months for this issue ¿ by product code: 95.By product family: 155 (47x smartset ghv gentamicin, 108x smartset gmv).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, b7, h6 (no code available (3191) is used to capture the surgical intervention and medical device removal).Corrected: b3.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical record ad 17 june 2019 was reviewed on 6 december 2019.On (b)(6) 2015: the patient underwent a right total knee arthroplasty secondary to severe degenerative joint disease, valgus deformity and tricompartmental changes.Attune implants were used with depuy cement x2.The patella was resurfaced.No intraoperative complications were noted.On (b)(6) 2017: the patient underwent a revision of the right knee secondary to pain, stiffness, swelling and suspected tibial loosening.Intraoperatively, the surgeon found synovitis; scar tissue; gross tibial loosening at the cement to implant interface; a small crack in the anterior tibia with no intervention noted; and a small anteromedial proximal tibial metaphyseal cyst.Although the femoral component was well fixed, the surgeon opted to remove it anyway.There were no intraoperative complications.Pmh: atrial fibrillation, pacemaker, sleep apnea, severe degenerative joint disease (right knee).Doi: (b)(6) 2015; dor: (b)(6) 2017 (right knee).

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> update 08-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot
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> device history reviewed: no non-conformances on this batch.Final micro and sterility tests passed.Complaints database searched: a complaint database search on the provided lot number found 2 additional reports related to implant loosening, and 3 unrelated reports.Total for lot number: 5 (com-270533, com-308096, pc-000093617, pc-00093737, pc-000295799) complaints received by cmw in the last 12 months for this issue ¿ by product code: 95 by product family: 155 (47x smartset ghv gentamicin, 108x smartset gmv) ¿dmf# - 13704 ¿trade name ¿ gentamicin sulphate ¿active ingredient(s) ¿ gentamicin sulphate ¿dosage form - powder ¿strength ¿ 1.0g active in our cements corrected: d2b, d3, g1.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 8718784
• MDR Text Key: 148735698
• Report Number: 1818910-2019-96423
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8010566
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR