MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-007

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

The patient was revised to address loosening of the tibial component at the cement to implant interface.Depuy cement was used.Doi: (b)(6) 2015 ; dor: (b)(6) 2017 ; right 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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.

Manufacturer Narrative

Patient code: no code available (3191) used to capture the surgical intervention, medical device removal, no information available the concomitant insert and patella has been changed to unk insert and unk patella as per to do.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: description of event or problem, other relevant history, device identification, medical products & therapy dates, device manufacture date, evaluation codes.Corrected: patient identifier.

Event Description

Medical record ad (b)(6) 2019 was reviewed on (b)(6) 2019.(b)(6) 2015: the patient underwent a right total knee arthroplasty secondary to pain and degenerative joint disease.Attune implants were used.Depuy cement x2 was used.The patella was resurfaced.No intraoperative complications noted.(b)(6) 2017: the patient underwent a revision of the right knee secondary to suspected loosening.Intraoperatively, the surgeon discovered tibial loosening at the cement to implant interface; and the surgeon also noted femoral component loosening likely at an unknown interface with notably soft bone.No intraoperative complications were noted.Doi: (b)(6) 2015.Dor: (b)(6) 2017 (right knee).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot null device history batch null device history review null if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FB TIB BASE SZ 7 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 7180164
• MDR Text Key: 96930868
• Report Number: 1818910-2018-50818
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042419
• UDI-Public: 10603295042419
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-00-007
• Device Catalogue Number: 150600007
• Device Lot Number: 8059989
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR