MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Adhesion(s) (1695); Edema (1820); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)

Event Date 04/04/2018

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

Attune knee claim record received.Claim record alleges reflex sympathetic dystrophy syndrome (rsd) or pain, emotional anguish, injuries, disfigurement or deformity, internal rotation of the femoral component and loosening of the tibial tray at an unknown interface.Unknown cement was used.Doi: (b)(6) 2016.Dor: (b)(6) 2018; right knee.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Patient received a right attune tka to treat pain secondary to severe medial compartment arthrosis and moderate patellofemoral compression of the right knee.The patella was resurfaced, and unknown cement was utilized.The surgeon notes the patient had a very large popliteal tendon which required a small release to be able to seat the insert.The surgeon further notes there were grades 2-3 chondromalacia changes to the natural knee joint.The procedure was completed without complications.Part/lot information was not provided.Dor: 04 apr 2018: patient received a right knee revision to treat pain secondary to tibial tray loosening and migration.Upon entering the joint, the surgeon identified and excised periarticular scar tissue.The femoral component was well-fixed but revised.The tibial tray had subsided into varus and was severely loose at the cement to implant interface.The surgeon identifies several areas of bone loss along the tibia.The patella was retained.There was no reported product problem with the explanted tibial insert.The patient was revised with competitor products utilizing competitor cement.

Manufacturer Narrative

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: a2 (dob and age), b5, b7, d11 and h6 (patient codes); corrected: h6 (device codes).H6 patient code: no code available (3191) used to capture the bone injury.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.

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.Patient code: no code available (3191) was used to capture joint crepitation.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) 2016, the patient underwent a primary right knee arthroplasty with no indicated intra-operative complications.On (b)(6) 2018, the patient underwent a right knee revision due to pain, emotional distress, disfigurement, adhesion, tibial bone injury, swelling, effusion, mild patellar crepitus, and tibial tray subsidence and loosening at the cement to implant interface.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.Competitor products and cement were implanted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : patient product x-ray images have been provided for review.No device associated with this report was received for examination.Provided images are jpeg files within patient medical records.Depuy synthese 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.Device history lot : no lot information available.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: UNK ATTUNE KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10033406
• MDR Text Key: 190170467
• Report Number: 1818910-2020-11818
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 MM ANATOMIC PATELLA; 7 MM RP INSERT; FEMUR SIZE 5 NARROW; TIBIA SIZE 3; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female