MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-00-002
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Primary operative notes (b)(6) 2016 indicate the patient received a bilateral total knee replacement due to end stage osteoarthritis.The patella was resurfaced bilaterally, and competitor cement was utilized x2 bilaterally for a total quantity of 4.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2020 indicate the patient received a right total knee revision due to pain, failed right knee replacement with gross loosening and varus collapse of the tibia, osteolysis and malalignment of the femoral and patella components.Upon entering the joint, parapatellar adhesions were released and synovectomy was performed.The tibial component was easily removed, loosening noted at the cement to implant interface.Competitor implants were utilized at this revision.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016.Dor: (b)(6) 2020; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.

• Brand Name: ATTUNE FB TIB BASE SZ 2 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10454761
• Report Number: 1818910-2020-18793
• Device Sequence Number: 19856777
• Product Code: JWH
• UDI-Device Identifier: 10603295042365
• UDI-Public: 10603295042365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 12/31/2023
• Device Model Number: 1506-00-002
• Device Catalogue Number: 150600002
• Device Lot Number: 7838430
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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 FB TIB BASE SZ 2 CEM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE PS FEM RT SZ 3 CEM; COMPETITOR (STRYKER) BONE CEMENT; COMPETITOR (STRYKER) BONE CEMENT; ATTUNE FB TIB BASE SZ 2 CEM; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS FB INSRT SZ 3 5MM; ATTUNE PS FEM RT SZ 3 CEM; COMPETITOR (STRYKER) BONE CEMENT; COMPETITOR (STRYKER) BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR