MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-00-008

Device Problems Failure To Adhere Or Bond (1031); Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Edema (1820); Muscular Rigidity (1968); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 05/14/2018

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

Patient was revised to address pain and loosening of the tibial component at cement to implant interface.Cement manufacturer is from depuy.Doi: unknown; dor: (b)(6) 2018; left 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.

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, b7, d4(lot#, doi), d11, h4 and h6(patient).H6 patient code: no code available (3191) used to capture device revision or replacement patient code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After review of medical records, it was stated that the patient was brought to the operating room for a left knee manipulation under anesthesia on (b)(6) 2017 to address left knee stiffness and adhesions.The adhesions were audibly heard to release, and flexion to 120 degrees was restored, as well as full extension.The patient underwent a left knee revision on (b)(6) 2018 to address persistent pain and loosening of the tibial tray, noted intraoperatively to be loose at the cement to implant interface.Tibial tray and tibial insert were revised; femur and patella were retained.There were no reported complications.Doi: (b)(6) 2017; dor: (b)(6) 2018; left knee.

Event Description

Additional information received stated that the patient was experiencing pain and swelling.The patient also indicated that he had a bone scan done and it showed movement of the tibial component.

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 synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update (b)(6) 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 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7582453
• MDR Text Key: 110482781
• Report Number: 1818910-2018-61649
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042426
• UDI-Public: 10603295042426
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-008
• Device Catalogue Number: 150600008
• Device Lot Number: 8269831
• 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 MOD DOME PAT 41MM XLK; ATTUNE PS FB INSRT SZ 10 6MM; ATTUNE PS FEM LT SZ 10 CEM; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104