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

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 07/07/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary : 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

This mdr report is related to mdr report numbers 3011632150-2022-00046 and 3011632150-2022-00047.The patient was treated as part of the mimics 3d usa post-market observational study on (b)(6) 2021.The subject was implanted with three biomimics 3d stents (a 7.0 x 150mm (this report), and two 7.0 x 125 mm stents) to treat a denovo lesion of the sfa ostial to sfa distal third artery in the left leg.A contralateral approach was used and the lesion was prepared using pre-dilation with percutaneous transluminal angioplasty (pta) and atherectomy.The treated segment was post-dilated with percutaneous transluminal angioplasty (pta).On (b)(6) 2022, an event of occlusion was reported.It was reported as "not related" to the device or procedure but was due to a worsening pre-existing condition.It was also reported as target lesion related.The patient outcome was reported as resolved/recovered.The first intervention was a laser atherectomy and attempted atherectomy/crossing of the lesion in the sfa proximal third to proximal popliteal segment that took place on 24-jan-22.A subsequent intervention on 24-feb-22 involved an additional bm3d stent placement, pta/standard balloon angioplasty and laser atherectomy on the sfa proximal third to proximal popliteal segment with 40-50% residual stenosis.The patient underwent duplex ultrasound (dus) on 25-mar-22 which showed a partial stent occlusion.The patient had also developed left leg claudication.On 29-jul-22, atherectomy and angioplasty of the left sfa proximal third to proximal popliteal was conducted but a successful revascularisation was not achieved.A referral for a femoropopliteal bypass was made.On 14-aug-23, a peripheral angiogram was performed at a hospital by another physician.On 19-sep-23, a left femoral endarterectomy and profundaplasty were conducted.The devices remain implanted.Veryan received additional information in relation to this event on 19-jan-24.

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.Pe code was updated from implant loosening: interface - unknown to implant loosening: interface - cement to implant.

• 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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17404444
• MDR Text Key: 319859959
• Report Number: 1818910-2023-15305
• 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: 07/27/2023
• 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?: 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
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/27/2023
• 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: 08/12/2014
• 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 PS RP INSRT SZ4 5MM; 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 INSERT; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female