MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number 3092040

Device Problems Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994); No Code Available (3191)

Event Date 10/31/2018

Event Type  Injury  

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.

Event Description

Patient was revised to address pain and loosening of the tibial component at cement to implant interface.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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.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: d4 (lot, catalog, udi), h6 (no code available (3191) is used to capture the medical device removal).Corrected: a1, d1, d2.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 and ad 21 june 2019 were reviewed on 9 december 2019.On (b)(6) 2017: the patient underwent a right total knee arthroplasty.Attune implants were utilized with depuy cement x2.Patella was resurfaced.No intraoperative complications were noted.On (b)(6) 2018: the patient underwent a revision of the right knee for pain, mild effusion, and radiographic detection of increased bone uptake in femur and tibia.Intraoperatively, the tibia tray was found internally rotated and surgeon notes implies tibial tray loose at implant-cement interface as the component disengaged from cement mantle with one attempt while leaving cement mantle adhered to tibia.No infection.Patella was not revised.Only the tibia tray and poly insert were replaced.On (b)(6) 2018: patient diagnosed with right knee wound dehiscence with superficial infection.Patient received irrigation and debridement due to infection.Intraoperatively, surgeon found arthrotomy to completely intact and not able to express fluid from arthrotomy itself.No implants removed at this procedure.On (b)(6) 2018: patient diagnosed with infected right knee arthroplasty and receives resection of right knee arthroplasty with placement of dynamic spacer.Patient received a complete synovectomy and all components (tibia, femoral, patella, insert) were removed.Surgeon then implanted size 4 sigma femoral component and antibiotic spacer both cemented in place (cement manufacturer not identified).On (b)(6) 2019: patient receives a total revision knee arthroplasty.Femoral component (implanted on (b)(6) 2018) and antibiotic spacer (implanted on (b)(6) 2018) both removed and replaced with non-depuy revision knee system with unidentified manufacturer cement.Doi: (b)(6) 2017.Dor: (b)(6) 2018 (tibial tray and insert).Doe: (b)(6) 2018 (irrigation and debridement).Dor: (b)(6) 2018 (tibial tray, insert, femoral, patella).Dor: (b)(6) 2019 (sigma femoral).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 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: device history reviewed 07 april 2020.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.(b)(4), units released.Lot expiry date: 30 june 2018.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw 46582
• MDR Report Key: 8101606
• MDR Text Key: 128270331
• Report Number: 1818910-2018-76267
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 3092040
• Device Lot Number: 8341093
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/07/2018; 12/10/2019; 08/26/2021
• Supplement Dates FDA Received: 12/07/2018; 01/06/2020; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE PS FEM RT SZ 7 CEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 113