MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK HIP FEMORAL STEM ACTIS

Catalog Number UNK HIP FEMORAL STEM ACTIS

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Joint Dislocation (2374); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing - outcomes and costs associated with total hip replacement with actis, accolade, ml taper and avenir.13,405 patients were implanted with actis for tha or hhr.There was no mention of acetabular cup or acetabular liner manufacturer.3 month follow up included 12,552 patients.1 patient with aseptic loosening.15 patients with fracture.39 patients with dislocation.50 patients with superficial infection.8 patients with deep infection.6 revisions reported.6 month follow up included 11,578 patients.1 patient with aseptic loosening.15 patients with fracture.35 patients with dislocation.51 patients with superficial infection.11 patients with deep infection.6 revisions reported.12 month follow up included 9, 572 patients.1 patient with aseptic loosening.11 patients with fracture.29 patients with dislocation.45 patients with superficial infection.10 patients with deep infection.5 revisions reported.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the 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.If additional information is made available, the investigation will be updated as applicable.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP FEMORAL STEM ACTIS
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 18826270
• MDR Text Key: 336862276
• Report Number: 1818910-2024-04922
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM ACTIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 FEMORAL HEAD; UNK SELF CENTERING HEAD
• Patient Outcome(s): Required Intervention