MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 4; HIP FEMORAL STEM

Model Number 1010-12-040

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 circulator opened the actis stem implant box, she noticed that the side of the blister pack was broken.She did not present the implant to the sterile field or peel back the sterile package.All pieces broken from the blister pack were recovered in the box and there was no patient involvement.Another implant was used as a replacement.I am returning the implant in its original packaging.Doe: (b)(6) 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned packaged stem confirms the reported observation.The root cause for the damage is suspected to be from distribution or inadvertent user handling.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: based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to the packaging process contained in the manufacturing records that would contribute to the reported event.Records review not performed.

• Brand Name: ACTIS COLLARED HIGH SIZE 4
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11748256
• MDR Text Key: 248157632
• Report Number: 1818910-2021-09207
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380566
• UDI-Public: 10603295380566
• Combination Product (y/n): N
• PMA/PMN Number: K150862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-12-040
• Device Catalogue Number: 101012040
• Device Lot Number: J99Y01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1