MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL STEM C-STEM

Catalog Number UNK HIP FEMORAL STEM C-STEM

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

Patient Problem Limb Fracture (4518)

Event Date 07/31/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: madanipour s, singh p, patel a, beg r, sha m, grewal is, iranpour f, subramanian p.Subsidence in centraliser sign: a novel tool to help predict early subsidence in periprosthetic femoral fractures around polished tapered stems treated with internal fixation.Cureus.2023 jul 31;15(7):e42742.Doi: 10.7759/cureus.42742.Pmid: 37654957; pmcid: pmc10467608.Objective and methods: when treating periprosthetic femoral fractures (ppf) around polished taper slip stems (pts), determining which patients can be successfully treated with internal fixation can be challenging.The authors identified the subsidence-in-centralizer (sinc) sign as a radiographic feature of ppf around pts stems.The purpose of this retrospective study is to test the hypothesis that a positive sinc sign can help predict a poorer outcome for the fixation of ppffs.Retrospective identification of all cases of periprosthetic hip fractures presenting to a single hospital system in the united kingdom between january 2011 and december 2020 was performed and 54 patients identified for the study.Of the 54 patients, three were implanted with depuy c-stem femoral stems.The remaining 51 patients received competitor implants and will be excluded from this complaint.The cement restrictor utilized is a competitor product.The authors do not provide the manufacturer of the cement utilized with the stems.This complaint will capture the results associated with the depuy c-stems.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: c-stem femoral stem patient specific adverse event(s) and provided interventions associated with depuy devices: 84-year-old patient sustained a ppff around the partially cemented left femoral stem treated with orif.The stem subsequently subsided 6mm and was revised to treat pain secondary to loosening of the femoral stem.84-year-old patient sustained a ppff around the cemented left femoral stem treated successfully with orif.50- year-old patient sustained a ppff around the cemented left femoral stem treated successfully with orif.

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 C-STEM
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 19183889
• MDR Text Key: 341120685
• Report Number: 1818910-2024-09131
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/25/2024

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 C-STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/03/2024
• 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