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

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

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

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Deformity/ Disfigurement (2360); Swelling/ Edema (4577)

Event Date 07/07/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary
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> no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Attune litigation record received.Litigation record alleges defective depuy attune knee system, defective smartset hv bone cement 40g, pain, swelling, joint stiffness, nickel allergy, suffering, impairment, disfigurement, pecuniary loss, economic damages and loosening of the tibial component at an unknown interface and aseptic loosening.Depuy cement were used.Doi: (b)(6) 2015 dor: (b)(6) 2016 left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not perform as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

The attached medical records capture the results of the patient's cardiac stress test and echocardiogram.It also captured the operative notes for hand and shoulder soft tissue repairs, and the removal of a competitor left knee orif unrelated to a depuy device.Doi (b)(6) 2015: female patient received a left knee depuy attune tka to treat pain, stiffness, and end stage arthrosis.The native patella was noted to be thin and resurfaced and depuy smartset cement x2 and cmw cement x1 were utilized.The surgeon notes the native patella was very thin requiring additional cement for secure fixation.The procedure was completed without complications.The primary part/lot is provided on pp.211 of the medical records entitled medical records ad (b)(6) 2024 (2).Doe: (b)(6) 2015: patient received a left knee mua with arthroscopic lysis of adhesions to treat pain, stiffness, and swelling secondary to adhesions.Upon entering the joint, the surgeon performed a synovectomy and debrided adhesions before performing the manipulation.The surgeon notes a pain pump was inserted during the procedure.The procedure was completed without complications.(pp 331).Dor: (b)(6) 2016: patient received a left knee revision to treat pain, swelling, stiffness, and adhesions secondary to loosening and subsidence of the tibial tray.Upon entering the joint, the surgeon debrided adhesions.The tibial tray was subsided and loosened and debonded at the cement to implant interface.The femoral component was well-fixed but revised to accommodate the revision construct.There was no reported product problem with the revised tibial insert.The surgeon notes that there was an avulsion of the patellar tendon that was re-fixed to the tibia with a staple.The patella was well fixed and retained.The patient received a competitor revision construct utilizing competitor cement and a pain pump.The procedure was completed without complications.(pp.524).The only depuy products retained are the patella, smartset cement x2 and cmw cement x1.This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016: patient has left calf postoperative dvt.Treated with blood thinner medication.Follow-up doppler determines the dvt resolved without further intervention.Doe: (b)(6) 2016: patient received a left knee mua with aspiration to treat pain, stiffness, and swelling.The surgeon notes there were adhesions and approximately 10 ml was aspirated from the knee.The procedure was completed without complications.(pp.684, only products depuy patella and cement x3).This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016: patient reports to er with severe back pain secondary to a fall.Patient was transported via ambulance because she lost consciousness after the fall.Radiology identifies osteopenia and determines a compression fracture of the l1 vertebrae and no indication of injury to the head.Imaging identifies a previous l4-s1 fusion with pedicle screw and rod fixation, intervertebral spacers and laminectomy at l4-l5 and, old right l1 transverse fracture deformity.Diagnosis after imaging is acute compression fracture superior endplate l1 with approximately 10% height reduction.Patient was referred for a kyphoplasty.This event is noted in the medical records but will not be captured as a pc as the patient has preexisting lumbar spine issues.This event is not associated with the retained patella and cement.Doe: (b)(6) 2016: patient received a l1 vertebral kyphoplasty to treat pain and an acute compression fracture secondary to a fall.Competitor cement was utilized, and the procedure was completed without complications.(pp.824).This event is noted in the medical records but will not be captured as a pc as the patient has preexisting lumbar spine issues.This event is not associated with the retained patella and cement.Dor: (b)(6) 2016: patient received a left knee revision of competitor products to treat pain, swelling, and stiffness secondary to an allergy to nickel.Upon entering the joint, significant scar tissue was debrided and a synovectomy was performed.All tibial and femoral competitor products were revised.The depuy patella secured with depuy cement was well-fixed and retained.The patient was revised with a competitor revision construct.The procedure was completed without complications.(pp.1022-1023).This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016: lle ultrasound identifies a postoperative dvt.Treated with oral anticoagulants.Follow-up imaging determines the dvt resolved without further intervention.(pp.1052) doe: (b)(6) 2016: patient transported to er via ambulance due to severe left knee pain.Patient was admitted as inpatient as she refused to be discharged due to intractable pain.Swelling was noted and imaging identified enlarged lymph nodes around the left knee.No source for the pain was identified in the available medical records.(pp.1146).This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016: patient reports to clinic with intractable left knee pain and effusion.Physician suspects possible infection and recommends a knee aspiration to relieve pain and test for infection.Patient refuses.Imaging identifies a stable, well-fixed left knee construct.(pp.1184).This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016: patient received a left knee mua to treat pain, stiffness, and adhesions.The procedure was completed without complications.This event is a continuing event associated with the first mua and revision and will be captured together on (b)(4).Doe: (b)(6) 2016 and (b)(6) 2023: left knee nerve block injections given to treat chronic left knee pain.(pp.1379).These events will be captured together as separate pcs.Doe: (b)(6) 2017: medical record summary notes infection was identified.No additional information provided for this visit.Begin medical records ad (b)(6) 2024 (1): dor: (b)(6) 2017: patient received a left knee complete removal of hardware and placement of an antibiotic spacer and arthrodesis/fusion to treat msse infection.Upon entering the joint, purulent fluid was evacuated and all competitor femoral and tibial devices removed.The operative note indicates a complete removal of all implanted devices but does not provide information regarding the condition of the depuy patella.A competitor antibiotic spacer is placed, and a competitor fusion nail is inserted along with a competitor tibial and femoral stem.At this time, no depuy devices remain in the left knee.The procedure was completed without complications.(pp.836) doi: (b)(6) 2015 dor: (b)(6) 2016 (tib, fem, insert) patella retained.This event will include all previous and subsequent muas and two revisions of competitor products as they are for chronic pain, stiffness, and swelling and are considered a treatment for the same event.Doe: (b)(6) 2016: dvt doe: (b)(6) 2016: dvt doe: (b)(6) 2016 and (b)(6) 2023: nerve block to treat pain dor: (b)(6) 2017: complete removal of hardware, arthrodesis, and antibiotic spacer placement.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.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork IN ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17393459
• MDR Text Key: 319828433
• Report Number: 1818910-2023-15167
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2014
• 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 32MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE RP TIB BASE SZ 3 CEM; DEPUY CMW 2 20G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; UNK ATTUNE FEMORAL; UNK ATTUNE KNEE TIBIAL TRAY; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female