MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-407

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 11/23/2020

Event Type  Injury  

Event Description

A call from a customer was received stating that "i want to know who i can talk about my knee replacement.I'm having a problem with it and it's been recalled even before my doctor put it in me.And since then i start to have problem with it.Should i call a lawyer for the compensation?" doi: (b)(6) 2019; dor: (b)(6) 2020; unknown knee.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).(b)(4) medical records ad 10 aug 2022 were reviewed on 08/22/2022 by clinician.On (b)(6) 2019 the patient had a left total knee arthroplasty to address degenerative joint disease.Depuy components, including depuy patella were used in conjunction with depuy cement x2.(part/lot page 4,5 of 848).On (b)(6) 2020, the patient had a revision left total knee to address instability and aseptic loosening.Prior to surgery the patient had pain, swelling, effusions, stiffness, and limping.During the procedure the surgeon observed significant synovitis, osteolysis.The tibial tray, insert, and femoral component were revised.In the operative notes, there were no specific loosening components noted, nor any interfaces provided.Competitor components were implanted during this surgery.(b)(6) 2021 right partial knee arthroplasty ¿ competitor products were used.Doi: (b)(6) 2019 dor: (b)(6) 2020 (left knee).Patient medical history: mild asthma, obesity, hypothyroidism, gerd, history of gastric bypass surgery.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

Medical records received.(b)(6) 2021: patient reports left knee pain at night.Treated with po pain meds.(b)(6) 2021: patient reports her left knee feels warm and stiff.X-ray reported no issues.No treatment was indicated and surgeon will continue to observe left knee.Only depuy implant is the patella (1518-20-035) which was implanted on (b)(6) 2019.All other implants are competitor.This was captured in (b)(4).

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: a4, b5 and b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The medical records received were for a cardiac stress test and echocardiogram.

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 that 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.

Event Description

Medical records received: update: medical records received on ad 4 mar 2024 were reviewed by a clinician to identify patient harms/product issues.The attached medical records reviewed clinic and pt notes dated (b)(6) 2022 due to diffuse, systemic joint pain and swelling attributed to the patient's fibromyalgia.No treatments were provided.The joint pain is already captured on (b)(4).There is no new information that would impact existing coding and/or us fda mdr determinations.Mrr activity closed.

Manufacturer Narrative

Product complaint # (b)(4).Is 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.

Event Description

Medical records included a multitude of various medical procedures and clinic visits that are either duplicative or not relevant to the event that is captured on this pc.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : a call from a customer was received stating that "i want to know who i can talk about my knee replacement.I'm having a problem with it and it's been recalled even before my doctor put it in me.And since then i start to have problem with it.Should i call a lawyer for the compensation?" the product was not returned to depuy synthes, however photos were provided for review.(b)(4), (b)(6) 2023' (b)(4),(b)(6) 2023' (b)(4), (b)(6) 2024.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed as the observed condition of the [attune ps fb insrt sz 4 7mm] would not contribute to the reported adverse event.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the device lot number is unknown, therefore a device history review could not be performed. if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE PS FB INSRT SZ 4 7MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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: 15281841
• MDR Text Key: 298459752
• Report Number: 1818910-2022-16490
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295049807
• UDI-Public: 10603295049807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• 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: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1516-40-407
• Device Catalogue Number: 151640407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• 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: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 4 7MM; ATTUNE PS FEM LT SZ 4 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 93 KG