MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) UNKNOWN MAE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number MAE UNK GEN

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

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2021

Event Type  Injury  

Event Description

Nishioka, s.T, andrews, s.N, mathews, k, nakasone, c.K; varus malalignment of short femoral stem not associated with post-hip arthro plasty fracture; archives of orthopaedic and trauma surgery (2022) 142:3533¿3538; doi.Org/10.1007/s00402-021-04244-w abstract background: periprosthetic femoral fractures are an increasingly common post-operative complication of total hip arthroplasty (tha).Though varus malalignment is known to increase fracture risk in standard-length femoral stems, varus malalignment is not as well studied in short stems.Therefore, the purpose of this study was to determine if varus malalignment contributes to early periprosthetic fracture risk in a cementless taper-wedged, short femoral stem.Materials and methods: this retrospective review included 366 consecutive patients (441 thas) having undergone tha via anterior appr oach by a single surgeon between july 2014 and december 2016.All patients received the same short, cementless femoral stem.Femoral component angle was measured on 6-week post-tha weight-bearing radiographs, with malalignment defined as a femoral component angle exceeding 0°±3°.Periprosthetic femoral fracture and aseptic loosening occurring within 2 years post-tha were recorded.Results: the final data analysis included 426 hips with a mean follow-up time of 32.9±10.2 months.Varus and neutral alignment occurred in 84 (19.6%) and 342 (79.9%) of stems, respectively.Three (0.7%) periprosthetic femoral fractures occurred within 2 years, all occurring in patients with neutrally aligned femoral stems.One (0.2%) stem failed due to aseptic loosening and was malaligned.Conclusion: despite nearly 20% of stems placed in varus alignment, three of the four early complications occurred in a neutrally aligned stem.Based on these results, forceful intraoperative realignment of a short femoral stem with good initial fixation may present an unnecessary increased risk of intraoperative fracture.Reportableevents: it was reported that the standard perioperative procedure included prophylactic antibiotic and acetaminophen by weight (unless contr aindicated), an intravenous injection of tranexamic acid (one gram) prior to incision and before arthrotomy closure and use of a bipolar sealant device.Three post-operative periprosthetic femur fractures and one acetabular cup revision (20.8 months) occurred in the neutrally aligned femoral implants.Additional complications included one patient having sustained a superficial infection and subsequently treated with antibiotics.One patient sustained a recurrent deep infection, which was initially treated with irrigation and debridement and exchange of the polyethylene liner and femoral head with 6 weeks of intravenous antibiotic treatment under the direction of an infectious disease specialist without sequelae.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN MAE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15826448
• MDR Text Key: 303936595
• Report Number: 1226420-2022-00049
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK GEN
• Device Catalogue Number: MAE UNK GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention