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

Catalog Number UNK HIP FEMORAL STEM CORAIL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Urinary Tract Infection (2120); Impaired Healing (2378); Thromboembolism (2654); Limb Fracture (4518); Physical Asymmetry (4573)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.The device catalog number is unknown; therefore, udi is unavailable.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled ¿comparison of early results after the initial total hip replacement of the collar versus the uncollar corail femoral shank: retrospective queuing study in 149 patients¿ written by weng xisheng, feng bin, and zhao lijuan published in the chinese journal of bone and joint surgery on (b)(6) 2021 was reviewed.The purpose of this study was to review first-time that patients with or without corail femur handle, both with and without corail stem produced by the same company, were compared with the early clinical efficacy and imaging results of the two groups of patients.It is intended to provide clinical reference.149 hips were included within the study.All patients were implanted with a corail stem, pinnacle cup, and ceramic on ceramic interface.70 hips were included within the collared group and 79 within the collarless group.Adverse events: nine stems had migration less than 1mm.Bone dissolution is asymptomatic in all cases and implant components do not require intervention.One case of wound healing bad, after a drug change, recovered.One case, a deep vein thrombus appeared after the operation, and was fully recovered after anti-coagulation treatment.One case, a fracture of femur distance was found, without special treatment, and was healed during follow-up.One case, a urinary tract infection was fully recovered by anti-coagulation treatment.Leg length discrepancy was noted ¿ no intervention noted.Ectopic ossification was noted in one patient - no intervention noted.

• Brand Name: UNK HIP FEMORAL STEM CORAIL
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15949955
• MDR Text Key: 305159021
• Report Number: 1818910-2022-24883
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM CORAIL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/09/2022
• 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
• Patient Outcome(s): Required Intervention