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

Model Number	1506-10-008
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	12/11/2019
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
Patient received a right primary attune tka to treat severe osteoarthritis with valgus deformity.The patella was resurfaced and competitor cement x 2 was utilized.Of note- the patella sustained a lateral crack during patellar resection.The surgeon did not treat the crack as the area was invested with the tendon.He cemented the patellar button, and the surgery was completed without further complications.Patient received a right knee revision to treat aseptic loosening.Upon entering the joint, some peripatellar scar tissue was debrided.The tibial tray was grossly loose and debonded at the cement to implant interface and revised.The femoral component was well-fixed but revised with minimal bone loss.There was no reported product problem with the revised tibial insert.The patella was well-fixed and tracked nicely with the depuy pfc sigma revision construct and was thus retained.The procedure was completed without complications.Doi: (b)(6) 2016.Dor: (b)(6) 2019.Right knee.
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 RP TIB BASE SZ 8 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11930356
• Report Number: 1818910-2021-11756
• Device Sequence Number: 4345013
• Product Code: NJL
• UDI-Device Identifier: 10603295042624
• UDI-Public: 10603295042624
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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
• Report Date (Section B): 05/25/2021

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: 07/31/2026
• Device Model Number: 1506-10-008
• Device Catalogue Number: 150610008
• Device Lot Number: 8365910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/13/2021
• 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 MEDIAL DOME PAT 41MM.; ATTUNE PS FEM RT SZ 7 CEM.; ATTUNE PS RP INSRT SZ7 6MM.; ATTUNE RP TIB BASE SZ 8 CEM.; STRYKER.; STRYKER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR