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 Pain (1994); Limb Fracture (4518)

Event Date 06/01/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yun hh, lee ws, shin yb, yoon th.Periprosthetic occult femoral fracture: an unknown side effect of press-fit fixation in primary cementless total hip arthroplasty.Hip pelvis.2023 jun;35(2):88-98.Doi: 10.5371/hp.2023.35.2.88.Epub 2023 jun 2.Pmid: 37323549; pmcid: pmc10264232.Objective and methods: the objectives of this study were to examine the prevalence and risk factors for development of periprosthetic occult femoral fractures during primary cementless total hip arthroplasty (tha) and to assess the clinical consequences of these fractures.A total of 199 hips implanted between march 2012 and may 2019 were examined.All patients received a cementless depuy corail or trilock femoral stem.The manufacturer of the femoral heads is unknown but assumed to be depuy.The manufacturer of the acetabular devices is unknown therefore excluded from the complaint.Periprosthetic occult femoral fractures were defined as fractures not detected intraoperatively and on postoperative radiographs, but only observed on postoperative computed tomography (ct).Clinical, surgical, and radiographic analysis of variables was performed for identification of risk factors for periprosthetic occult femoral fractures.A comparison of stem subsidence, stem alignment, and thigh pain between the occult fracture group and the non-fracture group was also performed.In the fracture group, the intraoperative ppfs were treated with cerclage and the occult ppfs, identified on post-op ct scan, were treated with weight bearing.The authors did not always specify treatment.This complaint will capture the group and patient specific results for both the fracture and non-fracture groups based on the information provided.Patient specific results: pt1: 63- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 2: 65- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 3: 66-year-old female patient corail stem sustained intraoperative ppff treated with a cerclage wire.No further treatment noted during follow-up.Pt 4: 72- year-old female patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 5: 65- year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 6: 71-year-old male with a trilock femoral stem sustained an intraoperative ppff treated with cerclage.No further treatment was needed during the follow-up period.Pt 7: 67-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 8: 67-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 9: 71-year-old male patient with unk depuy femoral stem with a ct identified ppff.Treatment not specified.Pt 10: 75-year-old female patient corail stem sustained intraoperative ppff treated with a cerclage wire.The stem was revised one year later to fully treat the displaced fracture and associated thigh pain.

Manufacturer Narrative

Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.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.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 CORAIL
• 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: 18995415
• MDR Text Key: 338886506
• Report Number: 1818910-2024-06931
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/07/2024
• Supplement Dates FDA Received: 04/08/2024
• 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
• Patient Outcome(s): Required Intervention