MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE FEMORAL; KNEE FEMORAL IMPLANT

Catalog Number UNK ATTUNE FEMORAL

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

Patient Problems Fall (1848); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 02/16/2022

Event Type  Injury  

Event Description

Ad 26 feb 2024 litigation records received : on or about february 11, 2022 complained of the following due to chronic pain and limitation of use of his right knee.On jun 23, 2022 complained of right knee pain at rest and stiffness and instability of the right knee upon standing.He was using a cane because of concerns that it would give out.Additionally, patient reported issues with right hip and quadricep muscle weakness.On or about (b)(6) 2022, patient was seen in follow-up reported being perplexed, inability to ambulate and having right knee dysfunction.On or about september 26, 2022, patient , complained of stiffness and the need to wait before he started walking due to problems with his right knee and that he also experienced buckling of his right knee.On or about (b)(6) 2023, while going down a flight of stairs, right knee buckled and gave out, causing him to fall a flight of stairs in his home.As a result of the fall, patient was there after being admitted was an inpatient from (b)(6) 2023.Since the time of surgery patient continue to suffer excruciating pain, discomfort, and loss of mobility in his right leg, all of which have and will continue to cause significant physical, emotional, and psychological injury and damage.Doi: (b)(6) 2020.Dor: (b)(6) 2022.Affected side: right knee.

Manufacturer Narrative

Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.An evaluation of the manufacturing record could not be performed as the required product/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.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.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.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 18837914
• MDR Text Key: 336959790
• Report Number: 1818910-2024-05016
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

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: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/05/2024
• 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: UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY
• Patient Outcome(s): Required Intervention
• Patient Sex: Male