MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820035

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

Patient Problems Muscular Rigidity (1968); Pain (1994); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4) investigation summary no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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.Update 28-02-2024 update received on 27-feb-2024 did not have any additional details to be added in investigation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.B5 additional event information: medical records received on ad on (b)(6) 2024 were reviewed by a clinician to identify patient harms/product issues.Doe: on (b)(6) 2023 and (b)(6) 2023: patient received a left genicular nerve radiofrequency ablation under fluoroscopic guidance to treat chronic pain, swelling, and stiffness of the bilateral knees related to the genicular nerve.The only depuy implants are the patella and two smartset cements in the left knee.The procedure was completed without complications.Doe: on (b)(6) 2023: patient received right genicular nerve radiofrequency ablation under fluoroscopic guidance to treat chronic pain, swelling, and stiffness of the bilateral knees related to the genicular nerve.The only depuy implants are the patella and two smartset cements in the left knee.The procedure was completed without complications.These procedures are part of ongoing treatment for chronic pain.B3: date of event is an unknown date.E3 initial reporter occupation: lawyer h6: component code: appropriate term/code not available (g07002) used to capture no findings available.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

(b)(4) medical records ad on (b)(6) 2023 and (b)(4) medical records ad on (b)(6) 2023 were reviewed.On (b)(6) 2021: patient reports left knee pain at night.Treated with po pain meds.On (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.Doi: on (b)(6) 2019, doe: on (b)(6) 2021, left knee.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18817105
• MDR Text Key: 336668151
• Report Number: 1818910-2024-04859
• 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
• Report Date: 03/01/2024

1 Device was Involved in the Event

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: 151820035
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/01/2024
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Sex: Female