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

Catalog Number 150600004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reviewed medical records received on 14 may 2018.Records indicated patient received attune total knee replacements in both knees, utilizing competitor bone cement in both cases.The right knee was revised to address progressive pain and unspecified deformity of the knee, with aseptic implant loosening reported at both implant to cement interfaces of the femur and the tibia base plate components.Revising surgeon reported both femur and tibia were grossly loose in findings.He reported that the femur came loose from its cement mantle with instrument assistance.He stated that the tibia implant came out by hand, with no cement adhered to the tibia component.Cement mantles for both products were removed with (b)(4) instruments.The patella component was well-fixed and was not revised.With the exception of the patella, surgeon re-implanted competitor products.Doi: (b)(6) 2014; dor: (b)(6) 2017; (right knee).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7553951
• MDR Text Key: 109555908
• Report Number: 1818910-2018-60885
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150600004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 07/16/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR