MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ACTIS COLLARED HIGH SIZE 4; HIP FEMORAL STEM

Catalog Number 101012040

Device Problem Migration (4003)

Patient Problems Pain (1994); Limb Fracture (4518)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code 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.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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.Device history review: null.

Event Description

It was reported that on (b)(6) 2023, the primary surgery was performed via tha for oa on hip joint.There was no problem on ct scan at 1 week post-op.Later, the patient had pain in the affected area while traveling.The implant subsidence and fracture was confirmed by an x-ray and ct scan at an outpatient visit.The patient is now under observation.The revision surgery will be scheduled depending on the progression of subsidence and pain in the affected area.The surgeon commented ¿i thought actis was applicable in dorr a.However, even in dorr a, there may be bone morphology and implant size where the proximal medial collar of the implant cannot contact the medial bone cortex, as in this case, where the proximal is wide and the distal is narrow.¿ he also said that it may be that the collar contact could not be made completely, and that the settlement was caused by rotation in the direction of subtorsion, and that the load was applied locally to the inner calcar area.No further information is available.

• Brand Name: ACTIS COLLARED HIGH SIZE 4
• Type of Device: HIP 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: 17887308
• MDR Text Key: 325123159
• Report Number: 1818910-2023-20440
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10603295380566
• UDI-Public: 10603295380566
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202472
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101012040
• Device Lot Number: J5936A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male