MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES; PLATE,FIXATION,BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Multiple patient involved.Implantation date is unknown.This report is for an unk - plates: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from china reports an event as follows: this report is being filed after the review of the following journal article: tian z., et al (2020)failure of less-invasive stabilization system(liss) plating for periprosthetic distal femur fractures three case reports, medicine volume 99:pages 1-5 (china).This study presents a case report of 3 patients to analyze the reasons for less-invasive stabilization system (liss; synthes, west chester, pa) plates plate failure, and techniques that can be used to avoid failure.(case 1) a case of a (b)(6) year old female with left rorabeck type ii closed distal femoral fracture after a fall from the stairs.Had bilateral total knee arthroplasty surgeries 5 months prior due to severe oa.Fixation of the periprosthetic fracture was done using a 9-hole liss plate.Six screws the femoral condyle, and 4 screws were screwed in the proximal femur.Postoperatively, weight bearing was not allowed until a significant callus was seen.Subsequently, she came to the hospital for anti-osteoporosis treatment and follow-up was performed monthly.Seven months later, 3 distal and 1 proximal screw of her liss plate had broken; the side of the distal plate separated from the femoral condyle and could be seen clearly on x-ray.She underwent total knee arthroplasty revision surgery with rotating hinged knee prosthesis.Subcutaneous hematoma formed around the drainage tube 2 days later.Debridement was performed immediately under local anesthesia.Six months later, her fracture united, ambulated with 1 crutch, free of pain, with a knee range of motion (rom) of 0° to 100o.(case 2) a case of a (b)(6) year old female with a right rorabeck type ii fracture after a fall.Had a total knee arthroplasty surgery in both knees.She underwent liss plate fixation and significant callus formation was noted 6 months later.Had lateral knee pain after her internal fixation procedure physiotherapy, and pharmacotherapy did not relieve her pain sufficiently.During the follow-up, her fracture was united, but the gap of the lateral compartment was wider than before on the postoperative x-rays.She underwent liss plate removal with replacement of the total knee arthroplasty.Six months after this procedure, she could walk unaided, without pain, but with partial numbness around the surgical incision.(case 3) a case of a (b)(6) year old woman.Three distal screws were broken.Dislocation of the broken end was noted on her x-rays after a fall.Had total knee replacement on account of the right knee osteoarthritis and sustained a rorabeck type ii distal femoral fracture in a non-motor vehicle accident.Noted to have a solid union after liss plate fixation.Total knee arthroplasty revision surgery was performed the third day after the injury.At the last follow-up, she had no pain or limitations to activities of daily living activities.No further treatment was required.Final union was confirmed at 1 year after surgery for both case 1 and case 3.This report is for an unknown synthes less-invasive stabilization system (liss).This is report 6 of 10 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10751572
• MDR Text Key: 216836052
• Report Number: 8030965-2020-08293
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention