MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-710
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Osteolysis (2377); No Code Available (3191)
Date of Event	03/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Patient was revised to address tibial loosening.Loosening occurred at the cement/implant interface.Cement manufacturer is unknown.On (b)(6) 2013: the patient underwent a right total knee arthroplasty.Attune implants were utilized with unknown manufacturer cement.Patella was resurfaced.No intraoperative complications were noted.On (b)(6) 2016: the patient underwent a revision of the right knee for suspected loosening.Intraoperatively, surgeon noted the tibial tray loose at implant-cement interface.The femoral components were found well fixed.Surgeon notes osteolysis around edges of patella and clinically determines enough bone stock is present to revise patella.All components (patellar, femoral, tibial, insert) were replaced with depuy revision tc3 knee system with unknown manufacturer cement.No intraoperative complications were noted.On (b)(6) 2019: the patient underwent a revision under different surgeon of the right knee for suspected loosening.Medical record does not indicate if loosening was confirmed intraoperatively or indicate any implant failures.The patella was left intact.All other components (femoral, femoral fluted stem, femoral medial and lateral augments, tibial tray, tibial sleeve, tibial fluted stem, insert ¿ listed on page 11 of medical record ad (b)(6) 2019) were replaced.This complaint captures the first revision.Doi: (b)(6) 2013.Dor: (b)(6) 2016 (patella, femoral, tibial, insert).Dor 2nd: (b)(6) 2019 (femoral, femoral fluted stem, femoral medial and lateral augments, tibial tray, tibial sleeve, tibial fluted stem, insert).
Additional 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.

• Brand Name: ATTUNE CR FB INSRT SZ 7 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9546925
• Report Number: 1818910-2020-00385
• Device Sequence Number: 16729695
• Product Code: JWH
• UDI-Device Identifier: 10603295045922
• UDI-Public: 10603295045922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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: 1516-20-710
• Device Catalogue Number: 151620710
• Device Lot Number: 254609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM RT SZ 7 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 121