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

Model Number 1506-10-007

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: attune rp tib base sz 7 cem knee tibial tray component; unknown knee femur component; attune cr rp insrt sz 6 8mm knee tibial insert component; unknown knee patella component; unknown bone cement.

Event Description

Patient was revised to address pain, discomfort and loosening of the tibial tray at the cement to implant interface.Unknown cement was used doi: unknown; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

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, will be filed as appropriate.

Manufacturer Narrative

Patient code: no code available (3191) used to capture the medical device removal.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.

Event Description

Medical record ad 17 june 2019 was reviewed on 12 december 2019.(b)(6) 2016: the patient underwent a left total knee arthroplasty secondary to osteoarthritis.Attune implants were used.Depuy cement x2 was used.The patella was resurfaced.No intraoperative complications noted.(b)(6) 2018: the patient underwent a revision of the left knee secondary to pain, decreased range of motion and suspected tibial loosening.Intraoperatively, the surgeon discovered tibial loosening at the cement to implant interface and medial tibial osteolysis.The femoral and patellar components were well-fixed.No intraoperative complications were noted.Doi: (b)(6) 2016.Dor: (b)(6) 2018 (tibial components).

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.H6 patient code: no code available (3191) used to capture the surgical intervention.

• Brand Name: ATTUNE RP 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: 7893946
• MDR Text Key: 120867814
• Report Number: 1818910-2018-69904
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042617
• UDI-Public: 10603295042617
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1506-10-007
• Device Catalogue Number: 150610007
• Device Lot Number: 8098248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FEM LT SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR