MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-008

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Cyst(s) (1800); Inflammation (1932); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 08/19/2020

Event Type  Injury  

Event Description

Litigation complaint received ad 28 jun 2022.A doctors letter noted the patient had bilateral total knee arthroplasties on 11/18/2015.The doctors letter noted that on (b)(6) 2020 left knee revision.Prior to surgery the patient had reported having pain in right and left knee, with it worse on the left.Preoperative radiographs were noted to show loosening of the tibial component with some varus tilt.There was some evidence of subsidence noted as well.A preoperative examination showed effusion and some increased laxity.During the revision, the surgeon reported that the tibial component was found to be grossly loose at the cement/implant interface.The femoral component and patella were intact.At tibial sleeve and press-fit stem were utilized.Postoperatively it was determined that a periprosthetic fracture incurred at the time of the implantation of the longer tibial stem.Patient was prescribed a delay in weight bearing.Healing occurred within 5-6 months.The doctor's letter did not specifically mention which components were implanted during the primary surgery or revision, but it was implied that they were depuy products, as the lawyers letter noted the patient¿ left knee revision was attributable to the failure of the attune device.

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.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).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

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.H10 additional narrative:  e3 initial reporter occupation: lawyer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2015, the patient had bilateral knee arthroplasties to address arthrosis.There were no apparent complications noted during the surgery.(b)(6) 2020 the patient had a left knee revision to address loosening of the tibial tray at the implant/cement interface.The indications for surgery included swelling.During the surgery, the surgeon observed effusion, diffuse synovitis, and a cyst.The tibial tray and insert were revised.Depuy components were implanted during this procedure.(b)(6) 2020, pathology report notes the specimen had mild chronic inflammation, no neoplasms.

• Brand Name: ATTUNE FB TIB BASE SZ 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr; warsaw, IN 46580 ; 3035526892
• MDR Report Key: 15120889
• MDR Text Key: 296761557
• Report Number: 1818910-2022-14294
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042426
• UDI-Public: 10603295042426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-008
• Device Catalogue Number: 150600008
• Device Lot Number: 7979848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE PS FEM LT SZ 8 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 96 KG