MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ACTIS COLLARED HIGH SIZE 7; HIP FEMORAL STEM

Catalog Number 101012070

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

Fracture of an actis prosthetic neck; also an fracture of the ceramic insert; implantation: 2019 1st revision was at the year 2021.Reason: first fracture of the ceramic insert.Again implantation of an ceramic insert and also the ceramic head was changed; 2nd revision was (b)(6) 2024 - again fracture of the ceramic insert and also the actis neck broke.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.

• Brand Name: ACTIS COLLARED HIGH SIZE 7
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18969819
• MDR Text Key: 338502611
• Report Number: 1818910-2024-06512
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380597
• UDI-Public: 10603295380597
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K202472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101012070
• Device Lot Number: J1371T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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
• Treatment: UNK HIP ACETABULAR LINER CERAMIC
• Patient Outcome(s): Required Intervention