MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-004

Device Problems Loss of or Failure to Bond (1068); Migration (4003)

Patient Problems Adhesion(s) (1695); Pain (1994); Osteolysis (2377); Unspecified Tissue Injury (4559)

Event Date 11/10/2020

Event Type  Injury  

Event Description

Patient received a left attune knee to treat degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address pain, osteolysis, tibial insert wear, tibial bone injury, tibial tray migration, and tibial tray loosening at the cement to implant interface.The surgeon noted the removal of fibrinous tissue as well as removal of meniscus of tissue that had developed around the poly patella component.The poly patella component was intact with very little wear and was retained.The tibial insert, tibial tray, and femoral component were revised.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2014, dor: (b)(6) 2020, left knee.

Manufacturer Narrative

(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.

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 FB TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg, ringaskiddy co; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13170142
• MDR Text Key: 283261836
• Report Number: 1818910-2022-00227
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 7765846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB PS INSRT TR SZ6 5MM.; ATTUNE FB PS INSRT TR SZ6 5MM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FEM LT SZ 5 NAR CEM.; ATTUNE PS FEM LT SZ 5 NAR CEM.; ATTUNE PS FEM LT SZ 5 NAR CEM.; SMARTSET MV 20G - EO.; SMARTSET MV 20G - EO.; SMARTSET MV 40G - EO.
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female