MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 8; HIP FEMORAL STEM

Model Number 1010-12-080

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that when the surgeon opened the sterile blue envelope that contains the actis stem surgeon saw there was strands of lint on the under side of the collar.Surgeon removed them with a pick up.Upon further inspection surgeon saw more near the shoulder of the implant.Surgeon was uncomfortable implanting that stem so sales representative provided surgeon with the same size stem and that was then implanted in the patient.Sales representative was there to watch the stem come out of the sterile blue envelope with the described lint and also took a picture of the lint on the shoulder as the surgeon had already removed the lint found on the under side of the collar.There was a surgical delay of 2 minutes.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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: a manufacturing record evaluation was performed, for the finished device product: 101012080, lot#: m1689f.And no non-conformances /manufacturing irregularities were identified.

• Brand Name: ACTIS COLLARED HIGH SIZE 8
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16571951
• MDR Text Key: 311573931
• Report Number: 1818910-2023-06143
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380603
• UDI-Public: 10603295380603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-12-080
• Device Catalogue Number: 101012080
• Device Lot Number: M1689F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG