MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 5; HIP FEMORAL STEM

Catalog Number	101012050
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
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 the surgeon believes that there was an issue with the stem upon implanting.The stem sat proud relative to where the broach sat.The stem was not implanted and is being sent in for inspection.Unknown surgical delay.Doe: (b)(6) 2023.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information provided, "it was reported that the surgeon believes that there was an issue with the stem upon implanting.The stem sat proud relative to where the broach sat.The stem was not implanted and is being sent in for inspection.Unknown surgical delay." the actis collared high size 5 (p/n 101012050 lot d22040476) was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed no signs of damage or defects.Inspection of the porocoat passed all inspection criteria.There were no areas of surplus coating found.Dimensional inspection of the overall stem length, lateral coating length, and medial coating length all passed.The unknown broach was not returned, therefore, further comparisons could not be made.A review of the device history records revealed 10 parts were manufactured in this lot.No non-conformances or manufacturing irregularities were identified.A search of the complaint database found no additional complaints against the part and lot combination of the returned device.The overall complaint was unconfirmed as the observed condition of the returned stem would not contribute to the complained device issue.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 reported 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 - a review of the device history records revealed 10 parts were manufactured in this lot.No non-conformances or manufacturing irregularities were identified.
Additional 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.

• Brand Name: ACTIS COLLARED HIGH SIZE 5
• Common Device Name: HIP FEMORAL STEM
• 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: 18482535
• Report Number: 1818910-2024-00721
• Device Sequence Number: 21114060
• Product Code: MEH
• UDI-Device Identifier: 10603295380573
• UDI-Public: 10603295380573
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K202472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2024

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: 101012050
• Device Lot Number: D22040476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: Not provided; 02/16/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 01/18/2024; 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female