MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ARTIC/EZE TR BALL GRVD 28+1.5; JRN : FEMORAL TRIALS

Catalog Number	253081000
Medical Device Problem Codes	Break (1069); Naturally Worn (2988); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 or Problem Description
It was reported that trial head is worn out and possibly shedding plastic shards.Patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, ip-01894239 device property of -->none, device in possession of -->none, ip-01894240 device property of -->none, device in possession of -->none, ip-01894241 device property of -->none, device in possession of -->none, ip-01894242 device property of -->none, device in possession of -->none, ip-01894243 device property of -->none, device in possession of -->none, ip-01894244 device property of -->none, device in possession of -->none, ip-01894245 device property of -->none, device in possession of -->none, ip-01894246 device property of -->none, device in possession of -->none, ip-01894247 device property of -->none, device in possession of -->none, ip-01894248 device property of -->none, device in possession of -->none, ip-01894249 device property of -->none, device in possession of -->none, ip-01894250 device property of -->none, device in possession of -->none, ip-01894251 device property of -->none, device in possession of -->none, ip-01894252 device property of -->none, device in possession of -->none, ip-01894253 device property of -->none, device in possession of -->none, ip-01894254 device property of -->none, device in possession of -->none, ip-01894255 device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary according to the information received, "plastic trials are worn out, with damage to the plastic.Possible plastic shards." the product was not returned to depuy synthes, however photos were provided for review.See attachment microsoftteams-image (15), microsoftteams-image (14).The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.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: ARTIC/EZE TR BALL GRVD 28+1.5
• Common Device Name: JRN : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18177273
• Report Number: 1818910-2023-23701
• Device Sequence Number: 18034386
• Product Code: HWT
• UDI-Device Identifier: 10603295128946
• UDI-Public: 10603295128946
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 253081000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown