MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK TIBIAL TRIAL; JRN : TIBIAL TRIALS

Catalog Number UNK TIBIAL TRIAL

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the spring came off the tibial trial.

Manufacturer Narrative

Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> according to the information received: i have been made aware of a patient that has had an attune primary knee replacement at the above account.Surgeon messaged me over the weekend with the attached x-rays showing what looks like a spring which is normally situated to the underside of our insert trials.Surgeon said the patient is happy and was going to talk to them and as it's at the back of the knee possibly leave it.The product was not returned to depuy synthes, however photos were provided for review.See attachment ((b)(4).(b)(6)).The x-ray investigation revealed a foreign body remaining in patient, but there is no certainty that is the spring nor other device component of unk tibial trial or a j&j device.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 confirmed, however with the information provided is not possible to identify the embedded device/fragment.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
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> the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.

• Brand Name: UNK TIBIAL TRIAL
• Type of Device: JRN : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18013029
• MDR Text Key: 326631125
• Report Number: 1818910-2023-21782
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK TIBIAL TRIAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1