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 Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 11/02/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: pankratz c, cintean r, boitin d, hofmann m, dehner c, gebhard f, schuetze k.Early surgical care of anticoagulated hip fracture patients is feasible-a retrospective chart review of hip fracture patients treated with hip arthroplasty within 24 hours.J clin med.2022 nov 5;11(21):6570.Doi: 10.3390/jcm11216570.Pmid: 36362798; pmcid: pmc9659252.Objective and methods: authors sought to determine the effect of oral anticoagulation in patients receiving early endoprosthetic treatment within 24 hours after their hospital admission.A retrospective chart review of 221 patients from 2016 to 2020, who were treated either with hemi- (n = 209) or total hip arthroplasty (n = 12) within 24 hours after their admission, was performed.Of the 221, authors identified 68 patients who took platelet aggregation inhibitors (pai), 34 who took direct oral anticoagulants (doac) and 9 who took vitamin-k-antagonist (vka) medications.The primary outcome measures were the transfusion rate and the pre- and postoperative hemoglobin (hb) difference.The secondary outcome measures were the in-patient mortality and the rate of postoperative hematomas that needed operative treatment.All patients received depuy corail femoral stems paired with either depuy self-centering bipolar heads (209) or depuy pinnacle acetabular cups liners, and femoral heads (12).Results: overall, 62 patients (28%) needed blood transfusions during the in-patient stay with an asa classification, but the type of anticoagulative medication was not a significant predictor in the logistic regression.Anticoagulation with doac and grouped surgery times were positive predictors for a higher hb difference in the patients who did not undergo an intraoperative blood transfusion (n = 159).Postoperative hematomas only occurred in patients taking anticoagulative medication (four cases in pai group, and three cases in doac group), but the logistic regression showed that the anticoagulative medication had no effect.The in-patient mortality was significantly influenced by a high asa grading, but not by the type of anticoagulative medication in patients who were treated within 24 hours of admission.!7 patients died during their hospital stays, 9 from the non-anticoagulation subset, and 5 from the pau group, 2 from the doac group, and 1 from the vka group.Logistic regression showed that high asa classification was significantly associated with higher mortality risk, as was increased age of the patient.Conclusion: early endoprosthetic treatment of the anticoagulated hip fracture patient is safe, and a delayed surgical treatment to address anticoagulation is no longer justifiable.Complications: 7 patients: required revision surgery to address post-op hematoma 62 patients: required a blood transfusion.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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.

• 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: 18411328
• MDR Text Key: 331578778
• Report Number: 1818910-2023-26139
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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
• Date Manufacturer Received: 12/18/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention