MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 10; HIP FEMORAL STEM

Model Number 1010-11-100

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

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 sales rep was getting ready for a hip surgery and started to pull implants to load on his cart, he noticed a funny sound in one of the actis boxes.As he shook the box, it sounded like a few pieces of plastic were rumbling around.When he opened the box the sterile packaging seem to be cracked & a few pieces of plastic fell out.The implant was not suitable for surgery.He then requested a replacement and sent this one back to their home office.Doe: (b)(6) 2020.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the provided photographs confirms the reported observation.The root cause is attributed to post distribution damage.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: lot j6639x.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.It is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Device history review: lot j6639x.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

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 STD SIZE 10
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10137684
• MDR Text Key: 194630304
• Report Number: 1818910-2020-13545
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295380504
• UDI-Public: 10603295380504
• 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,Followup
• Report Date: 06/01/2020

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
• Device Operator: Health Professional
• Device Model Number: 1010-11-100
• Device Catalogue Number: 101011100
• Device Lot Number: J6639X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 07/23/2020
• Supplement Dates FDA Received: 06/26/2020; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1