MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-005

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 03/21/2016

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

Attune knee claim letter received.Claim letter alleges injury, mechanical loosening, pain, and disfigurement.It was reported that upon revision on (b)(6) 2016 that loosening occurred at implant-cement interface.Cement manufacturer used was unknown.Doi: (b)(6) 2014; dor: (b)(6) 2016; right knee.

Manufacturer Narrative

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

Event Description

Medical record ad (b)(6) 2019 was reviewed on (b)(6) 2019.(b)(6) 2014: the patient underwent a right total knee arthroplasty.Attune implants were utilized with depuy cement x1.Patella was resurfaced.No intraoperative complications were noted.(b)(6) 2016: the patient underwent a revision of the right knee for pain and suspected loosening.Intraoperatively, surgeon noted tibial tray to be loose at implant-cement interface.The femoral and patella were both found fixed but femoral component was revised.Patella was not revised.All other components were replaced (tibial tray, insert, femoral) with non-depuy revision knee system with non-depuy cement.No intraoperative complications were noted.Doi: (b)(6) 2014.Dor: (b)(6) 2016 (tibial, insert, femoral).

Manufacturer Narrative

Product complaint # (b)(4) 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.H10 additional narrative: added: b5, d4 (lot, expiration date), d11, h4, h6 (no code available (3191) is used to capture the medical device removal) corrected: d6.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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.¿ added: d11 and h6 (patient).Corrected: h4.Removed: (3191) medical device removal.No code available (3191) is used to capture joint instability and device revision or replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: 21-jan-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 7566071
• MDR Text Key: 109953178
• Report Number: 1818910-2018-61255
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295042396
• UDI-Public: 10603295042396
• 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,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1506-00-005
• Device Catalogue Number: 150600005
• Device Lot Number: 6547044
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FB INSRT SZ 5 8MM.; ATTUNE PS FEM RT SZ 5 NAR CEM.; SMARTSET GMV 40G US EO.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR