MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

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

Patient Problem Limb Fracture (4518)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

This complaint is from a literature source.The following literature cite has been reviewed: kinney mc, ho h, hamilton wg.Aahks best podium presentation research award: femoral perforation during direct anterior approach total hip arthroplasty: incidence, cohort characteristics, and management.J arthroplasty.2022 aug;37(8s):s721-s726.Doi: 10.1016/j.Arth.2022.02.110.Epub 2022 mar 8.Pmid: 35271970.Objective and methods: cortical perforation during femoral preparation is a recognized complication of total hip arthroplasty (tha) but the incidence, patient characteristics, management, and outcome have not been described for the direct anterior approach (daa).A database query of all primary and conversion daa thas performed by a single surgeon from 2009 to 2021 was used to identify hips that sustained a recognized intraoperative femoral perforation.Radiographs were used to assess stem subsidence, dorr femur type, and canal flare index.Among 3,973 thas, 16 patients (0.4%) sustained perforations during broaching including 8 males and 8 females.The cups and liners implanted during the primary thas are unknown and not assumed to be depuy products.All stems were manufactured by depuy.The manufacturers of the femoral heads are unknown but assumed to be depuy products.This complaint will capture the 16 patients detailed in the study.Case 1: doi: 2010.76- yo- male patient received a right tha secondary to posttraumatic osteoarthritis, renal dystrophy, and previous internal fixation of femoral neck fracture repaired with 3 cancellous screws.Upon entering the joint, the surgeon removed the femoral screws.The patient received trilock stem.The surgeon identified a dorr c type fracture after intraoperative fluoroscopy to confirm correct placement of the trilock stem.The surgeon believed the perforation occurred during daa broaching but could have occurred during stem placement due to potential bone weakness in the areas of previous unknown screw removal.The trilock stem was replaced with a longer, dual wedged, metaphyseal filling corail stem and the ppf was repaired with cerclage to prevent fracture propagation.The procedure was completed without complications.Patient medical history: dialysis dependence, renal dystrophy, failure contralateral unknown tha requiring wheelchair use, wegener¿s granulomatosis.Case 2: doi: 2011: 70- you- female patient with morbid obesity (bmi 44.4) received a left tha to treat osteoarthritis.The surgeon identified a dorr b type fracture after intraoperative fluoroscopy to confirm correct placement of the trilock stem due to intraoperative daa broaching.The stem was removed, the broach re-directed, and the trilock stem was successfully re-implanted.Caser 3: doi 2011.73- yo- female patient received a right tha to treat osteoarthritis and 30-degree knee flexion contracture.The patient sustained a dorr b type femoral fracture during daa broaching.The fracture was secured with a cerclage and the definitive trilock stem was implanted successfully.The article reports there was a postoperative dvt.No treatment for the dvt was specified, but the authors note the patient did not require a revision.Case 4: doi 2011.72- yo- male received a right tha to treat osteoarthritis.The patient received trilock stem.The surgeon identified a dorr c type fracture after intraoperative fluoroscopy to confirm correct placement of the trilock stem.The surgeon believed the perforation occurred during daa broaching but could have occurred during stem placement.The trilock stem was replaced with a longer, dual wedged, metaphyseal filling corail stem and the ppf was repaired with cerclage to prevent fracture propagation.The procedure was completed without complications.Case 5: doi 2013.59- yo- female received a left tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The corail stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 6: doi 2014.74- yo- male received a right tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The corail stem was implanted successfully, and no treatment provided for the femoral fracture.Case 7: doi 2014.55 yo male patient with bmi 31.4 received a left tha to treat ra and post-traumatic arthritis.The patient had a previous femoral neck fracture secondary to ra that was treated with an intramedullary rod fixation.The surgeon notes there were areas of sclerotic bone in the femoral canal.The patient sustained a dorr a type femoral fracture during daa broaching.The patient received a long, dual wedged metaphyseal filling corail stem.No treatment for the femoral perforation was provided.The procedure was completed without complications.Case 8: doi 2016.66- yo underweight female received a right tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 9: doi 2016.68- yo- overweight (bwi 34.5) male received a left tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 10: doi 2017.53- yo underweight (23.6 bmi) male received a right tha to treat osteoarthritis secondary to perthes disease.The patient sustained a dorr a type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 11: doi 2017.49- yo- obese (bwi 41.8) male received a right tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 12: doi 2017.41-yo- obese (bmi 41.0) female patient received a left tha to treat osteoarthritis.The patient had a previous acetabular and femoral neck fracture sustained during an mva, both of which were treated with 2 unknown trochanteric screws.The surgeon notes areas of bone weakness in the femoral canal around where the screws were removed.The patient sustained a dorr type c femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Intraoperative radiographs for case 12 in fig 1 on pp.5723.Case 13: doi 2018.81- yo- female received a left tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Intraoperative radiographic images for case 13 in fig.3 on pp.5724.Case 14: doi 2020.74- yo- female received a right tha to treat osteoarthritis.The patient sustained a dorr a type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 15: doi 2020.68- yo- overweight (bmi 39.9) male received a right tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.Case 16: doi 2020.53- yo underweight (19.0 bmi) male received a right tha to treat osteoarthritis.The patient sustained a dorr b type femoral fracture during daa broaching.The actis stem was implanted successfully, and no treatment provided for the femoral fracture.The procedure was completed without complications.

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.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15326947
• MDR Text Key: 298960531
• Report Number: 1818910-2022-16964
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• 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