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

Model Number 1506-00-002

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994)

Event Date 10/12/2018

Event Type  Injury  

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 Description

Primary operative notes (b)(6) 2016 indicate the patient received a left total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and competitor cement was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2018 indicate the patient received a left total knee revision due to pain and loosening of the tibial component.Upon entering the joint, profound stiffness and significant adhesions were encountered and removed.The tibial component was noted to be loose at the cement to implant interface.Femur, insert and tibial component were revised.Depuy products were implanted along with competitor cement.The surgery was completed without indication of complication by the surgeon.Doi: (b)(6) 2016.Dor: (b)(6) 2018.Left knee.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 FB TIB BASE SZ 2 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11155076
• MDR Text Key: 227783151
• Report Number: 1818910-2021-00893
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295042365
• UDI-Public: 10603295042365
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-002
• Device Catalogue Number: 150600002
• Device Lot Number: 8254496
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 4 7MM; ATTUNE PS FEM LT SZ 4 NAR CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR