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

Model Number 1506-00-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Numbness (2415); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: (b)(6).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation records received.Litigation alleges soreness, pain, stiffness, weakness, locking, catching, numbness and giving way.Scans shows marked uptake along the tibial components implying loosening and also lucency on the posterior aspect of the tibial stem, again consistent with loosening.During revision, the tibial based was noted to be grossly loosed at the cement to implant interface.Surgeon also noted that during inspection of patella there was a suggesting fracturing of the cement mantle and the patella was revised.Doi: (b)(6) 2016, dor: (b)(6) 2021.Right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records received indicated that "doi: (b)(6) 2016: patient received a right primary attune tka to treat djd.The patella was resurfaced and depuy cement was utilized.The procedure was completed without complications.Primary implants: attune pcl substituting femoral component size 4.Fixed-back tibial tray size 4.Posterior stabilizing insert size 2 x 10 mm.Patella size 38 mm.Dor: (b)(6) 2021: patient received a right knee revision to treat pain, instability, swelling, numbness, weakness, and stiffness secondary to tibial tray loosening.Upon entering the joint, the surgeon evacuated effusion.The tibial tray was grossly loose and debonded at the cement to implant interface and revised.The cement mantle on the medial side of the tibia was cracked.There was no reported product problem with the patella as it was well-fixed, but it was revised due to a crack on the patellar cement mantle.There was no reported product problem with the revised tibial insert.The femoral component was well-fixed and retained.The patient received attune revision products the procedure was completed without complications.Records indicate the patient received a left pfc sigma tka on 6-january 2016.The patella was resurfaced and unknown cement was utilized.The procedure was completed without complications.".

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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information 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).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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

On (b)(6) 2012, the patient had a left total knee arthroplasty to address degenerative joint disease.Depuy components including depuy patella were utilized during this procedure.Competitor cement was used (tobra) on (b)(6) 2016, the patient had a right total knee arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure, including depuy patella.No mention of manufacturer of cement.Right hip arthroplasty (b)(6) 2017 on (b)(6) 2017, the patient had a right total hip arthroplasty to address osteoarthritis.Depuy components were implanted during this procedure.On (b)(6) 2021, the patient had a right knee revision tibial and patellar components to address failed right total knee.The indications for surgery included: pain, swelling, and multiple preoperative studies report loosening of the tibial component and potential crack in cement mantle of the patella.During the procedure the surgeon observed that the tibial tray had debonded from the cement.The femoral component was well fixed and retained.There was a fracture of the cement mantle on the tibial side as well as the patella.Insert was revised with no allegation of deficiency.Depuy components, including depuy patella were implanted during this procedure.Medical records from (b)(6) 2021 report that an mr knee mars reportedly showed subchortical cystic change in the anterior portion of the proximal tibia at the base of the tibial tuberosity of right leg.

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: the device associated with this complaint was not returned.X-ray evidence provided was reviewed and did not find any implant related issue that would evidence implant loosening.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records evaluation mre was not performed.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12526762
• MDR Text Key: 273144488
• Report Number: 1818910-2021-21029
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 8202158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 05/13/2022; 06/02/2022; 07/06/2022; 07/20/2022; 11/20/2022; 02/02/2023
• Supplement Dates FDA Received: 05/26/2022; 06/03/2022; 07/25/2022; 08/10/2022; 12/07/2022; 02/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2015
• 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
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PCL SUBSTITUTING FEMORAL COMPONENT SIZE 4; ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE PS FEM RT SZ 4 CEM; FIXED-BACK TIBIAL TRAY SIZE 4; PATELLA SIZE 38 MM; POSTERIOR STABILIZING INSERT SIZE 2 X 10 MM; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; UNK CEMENT CMW; UNK CEMENT CMW; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; UNK CEMENT CMW
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female