MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-106

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 Description

It was reported that there is a complaint to report against a knee implant.The knee implant has problems.Medical records received.On (b)(6) 2018, the patient underwent a left knee revision to address, pain, inflammation, and synovitis.The tibial tray was loose at the cement to implant interface and the femoral component was loose at an unknown interface.There was extensive bone loss involving the tibia and femur.The tibial insert, tibial tray, and femoral component were revised.The patellar component was retained.The patient was revised with competitor implants.There were no indicated intra-operative complications.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The investigation could not draw any conclusions regarding the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Per the initial reporting; no additional investigative information will be provided.Investigational inputs were requested as indicated per internal procedures for this failure mode.The received medical records were reviewed by a depuy medical professional.From a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution to the reported event was identified.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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 PS FEM LT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11400312
• MDR Text Key: 234302273
• Report Number: 1818910-2021-04190
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041634
• UDI-Public: 10603295041634
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1504-10-106
• Device Catalogue Number: 150410106
• Device Lot Number: 7773969
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM LT SZ 6 CEM; STRYKER SIMPLEX BONE CEMENT; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM LT SZ 6 CEM; STRYKER SIMPLEX BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Weight: 80