MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED STD SIZE 6; HIP FEMORAL STEM

Model Number 1010-11-060

Device Problems Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Inadequate Osseointegration (2646)

Event Date 02/05/2020

Event Type  Injury  

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

The primary surgery was performed in 2019 via tha.It was reported that it was confirmed last month that sinking of the stem and loosening caused by aff, thus the removal surgery was performed by explanting the actis stem of the patient¿s left hip joint.The surgery was completed, and it was unknown whether there was a surgical delay or not.

Manufacturer Narrative

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.H10 additional narrative: corrected: h6 product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ACTIS COLLARED STD SIZE 6
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9741649
• MDR Text Key: 188684559
• Report Number: 1818910-2020-05719
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10603295380467
• UDI-Public: 10603295380467
• Combination Product (y/n): N
• PMA/PMN Number: K160907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1010-11-060
• Device Catalogue Number: 101011060
• Device Lot Number: HZ6046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention