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

Model Number	1010-11-100
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
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 STD SIZE 10
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10137684
• Report Number: 1818910-2020-13545
• Device Sequence Number: 19742041
• Product Code: LPH
• UDI-Device Identifier: 10603295380504
• UDI-Public: 10603295380504
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/25/2020; 07/23/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1