MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150410103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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 loosening of the tibial component at the unknown interface.Doi: unknown; dor: (b)(6) 2018; unknown knee.

Event Description

Discharge records indicate the patient received a primary left knee arthroplasty on (b)(6) 2013 to treat osteoarthritis.(b)(6) 2014: a pathology report and office visit notes within the medical records indicate the patient received a left knee revision to treat pain, swelling, and walking difficulty.The pathology report identified excised synovium with no evidence of infection.The radiographic images and the related reports indicated that there was loosening of an unknown tibial tray.An additional radiographic report identified left tha that was well-fixed, though there was no further evidence of a tha within the medical records.There was no further information pertaining to this revision.It is unknown if depuy products were revised or implanted.Clinic note (b)(6) 2018: patient reported knee pain, swelling, and walking difficulty after the knee ¿gave out¿.The physician noted that the patient reported she took two ambien and one xanax each night as a sleep aid.Physical exam showed that the left knee has normal alignment with some swelling and tenderness of the medial and lateral tibial plateau.Passive rom showed some pain with motion with no mid-flexion instability.Radiology reports showed progressive evidence of tibial tray loosening.(b)(6) 2018: patient received a left knee revision to treat pain, swelling, and walking difficulty secondary to loosening of the tibial tray.Upon entering the joint, the tibial tray was grossly loose and completely debonded at the cement to implant interface.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The procedure was completed without complications.The patient was revised with competitor products with unknown cement.Postoperative clinic notes indicated that the patient continued to have left knee pain consistent with healing.Postoperative radiographs identified a well-fixed and aligned revision tka.The patient was occasionally compliant with postoperative physical therapy.Doi: (b)(6) 2013.Dor: (b)(6) 2018.Left knee.

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.

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: added: b7.

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: added: b5 and h6 (patient).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received and reviewed: in addition to the previous harms indicated prior to the left knee revision on (b)(6) 2018, the patient was also experiencing stiffness, fatigue, and insomnia.

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

(b)(6) 2013: patient received a primary left attune to treat pain, swelling, numbness, weakness, and instability secondary to degenerative joint disease and osteoarthritis.The patient has a history of acl surgical repairs, patellar tendinopathy, and chondromalacia of the left knee.The surgeon notes the patient had extensive tricompartmental degenerative changes with full thickness cartilage defects on the femoral condyles and patellofemoral articulation.The surgeon noted the patient had evidence of previous acl repairs and natural left knee instability.The patella was resurfaced and competitor cement x 2 was utilized.The procedure was completed without complications.Clinic note on (b)(6) 2013: patient presented 4 weeks s/p left knee tka with pain, crepitus, swelling, and walking difficulty secondary to arthrofibrosis.X-ray reveals a well-fixed, stable left tka.Physician exam reveals some instability in extension.The physician refers the patient for a manipulation under anesthesia.(b)(6) 2013: patient receives a left knee manipulation under anesthesia to treat pain, crepitus, swelling, and walking difficulty secondary to arthrofibrosis.Rom from 0-135 degrees was easily obtained with little effort.Intraoperative x-ray showed no fracture or device loosening.No devices were revised.(b)(6) 2014: patient receives a posterior capsular release with insert revision to treat progressive pain, instability, swelling, and crepitus secondary to arthrofibrosis that was unresolved with the manipulation under anesthesia.Upon entering the joint, the surgeon identified and removed fibrotic tissue.The knee had moderate mid-flexion instability which was corrected with a posterior capsular release and scar tissue debridement.There was no reported product problem with the revised tibial insert.The patella, femoral component, and tibial tray were well-fixed and retained.The would was seeded with competitor antibiotic pellets.Tissue pathology confirm there was no infection or chronic inflammation.The procedure was completed without complications.(b)(6) 2018.Patient receive a left knee revision to treat pain, swelling, and walking difficulty secondary to loosening of the tibial tray.Upon entering the joint, the tibial tray was grossly loose and completely debonded at the cement to implant interface.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The procedure was completed without complications.The patient was revised with competitor products with competitor cement x 2 and competitor antibiotic pellets x 2.Postoperative clinic notes indicate the patient continues to have left knee pain consistent with healing.Postoperative radiographs identified a well-fixed and aligned revision tka.The patient was occasionally compliant with postoperative physical therapy.Doi: (b)(6) 2013.Doe: (b)(6) 2013 (mau for arthrofibrosis).Dor: (b)(6) 2014 (insert exchange for arthrofibrosis- previously unreported).Dor: (b)(6) 2018 (tka revision left knee captured on (b)(4).Left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 03-feb-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 PS FEM LT SZ 3 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10224740
• MDR Text Key: 200032047
• Report Number: 1818910-2020-14959
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 150410103
• Device Lot Number: 274368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 3 7MM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR