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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Nerve Damage (1979); Thrombosis (2100); Injury (2348); No Code Available (3191)
Event Date 12/06/2019
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown 95 degrees condylar blade-plate and screws/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/ or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: merckaert sr, fontanellaz-castiglione cd, fornari ed, tannast m (2019), double-plate compound osteosynthesis for pathological fractures of the proximal femur: high survivorship and low complication rate, archives of orthopaedic and trauma surgery, pages 1-12, (switzerland). The purpose of this study was to assess the mid- and long-term performance of compound double-plate osteosynthesis for proximal femoral pathological fractures. Between january 1990 and april 2016, 53 patients (61 procedures) with proximal femur fracture who under double-plate compound osteosynthesis were included in the study. There was a total of 26 male hips. The patients¿ mean age was 63. 5 +/ 12. 2 (range 39. 6 - 92. 7 year). The patients were divided into 2 groups: a ¿primary¿ group (46 patients) with all cases in which a double-plate compound osteosynthesis was performed as initial procedure and a ¿revision¿ group (15 patients) with all cases in which a double-plate compound osteosynthesis was performed as revision procedure after failed previous attempts of internal fixation (n
15). These patients were implanted with an unknown synthes 4. 5mm dynamic compression plate and an unknown synthes 95 degrees condylar blade-plate. A competitor¿s methyl-methacrylate cement was also used to augment the fixation devices. Postoperatively, the construct stability allows for immediate full postoperative weight-bearing as tolerated. Patients were followed on an interdisciplinary basis by oncologists, radio-oncologists, and/or by the orthopedic department. In this study, failure of the implant was defined as a plate breakage or secondary displacement of the fracture. The mean follow-up was 1. 83 years (range, 0. 2¿25. 5 years). At the moment of the last evaluation for this study, 5 patients were still alive, 1 patient was lost of follow-up and 47 patients were dead. Complications were reported as follows: (primary group): 3 patients had anemia. 1 patient had neuropraxia. 2 patients had urinary tract infections. 1 patient had a hematoma. 1 patient had tumor progression. 2 patients had compound osteosynthesis failures. 1 patient had cerebral vascular insult. (revision group): 5 patients had anemia. 1 patient had a prolonged wound secretion not requiring revision. 1 patient had deep vein thrombosis. 1 patient had urinary tract infections. 6 patients had compound osteosynthesis failures. 1 patient had a deep infection. 1 patient had a vascular complication. 4 patients had peri-implant failures. 1 patient had metastases progression with secondary hip exarticulation. 2 patients died 4 and 6 months after the procedure and showed no failure until then and 1 patient had no failure until his death 3 years later. A (b)(6) year-old male patient had a plate breakage at the shoulder of the blade plate. The patient was revised with tumor endoprosthesis. This report is for an unknown synthes 95 degrees condylar blade-plate and screws. It captures the reported events of surgical intervention, neuropraxia, deep infection, vascular complication, peri-implant failures, secondary displacement of the fracture, hematoma and deep vein thrombosis. This is report 2 of 5 for complaint (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key10234016
MDR Text Key201173224
Report Number8030965-2020-04650
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/06/2020 Patient Sequence Number: 1