MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS-FEMUR; PLATE, FIXATION, BONE

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

Patient Problems Arthritis (1723); Unspecified Infection (1930); Necrosis (1971); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown ao 90 degrees angled 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).Medical/surgical intervention required and loss of anatomical alignment after fracture reduction.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: schai pa, exner gu (2007), corrective imhäuser intertrochanteric osteotomy, operative orthopädie und traumatologie, volume 19, number 4, pages 368-388, (switzerland).The objective of this retrospective study is the surgical correction of deformities of the proximal femur caused by epiphyseal displacement by restorative (usually inflection and internal rotation) osteotomy at the intertrochanteric level with the aim of reducing both the offset disorder of the coxal end of the femur that is causing impingement and the prevalence of secondary coxarthrosis.From 1962 to 1972, 51 patients, with unilateral, moderate to severe slipped capital femoral epiphysis who were treated by corrective intertrochanteric imhäuser osteotomy were included in the study.There were 21 girls with a mean age of 12.6 years (range, 8.5-14.8 years) and 30 boys with a mean age of 14.6 years (range, 11.4-20.8 years)these patients underwent fixation of the femoral epiphysis using 2 unknown 3.0 mm steinmann nails with intertrochanteric osteotomy by excision of the wedge.Stabilization was done using an unknown ao 90 degrees angled blade plate for intertrochanteric femur osteotomies in adults and skeletally mature adolescents or an unknown ao 95 degrees condylar plate for small adults and adolescents.Clinical and radiologic follow-ups were done at 6-week intervals (until the osteotomy has consolidated).The clinical assessment included analysis of gait pattern, measurement of hip joint mobility and bilateral comparison with the neutral zero methods according to debrunner, and calculation of clinical scores according to jerre and also merle d¿aubigné et al.The radiologic evaluation based on anteroposterior pelvic overviews included grading of degenerative changes according to the bauer & kerschbaumer classification.Implant removal from 1 year postoperatively, if the growth plate is closed.The average observation time was 24.1 years (range: 20-29 years).The authors did not specify which of the 2 plate types were implanted for each patient.Thus, complications will be reported as follows: 14 hip joints were recorded to have moderate radiologic signs of degeneration (arthrosis grade i); symptoms of fatigue during high physical loading, restricted motion of lesser than 20 degrees compared to the contralateral side.9 hip joints were recorded to have poor results with more distinct radiologic signs of degeneration (arthrosis grade ii/iii); symptoms of limitations in daily activities; functional deficits of more than 20 degrees compared to the contralateral side.8 patients had a gait pattern with slight limping due to shortening.1 patient had a positive trendelenburg sign.35 patients had a residual shortening of the affected extremity of 0.9 cm (0.5-2.0 cm) on average was measured; in 2 of these patients, the contralateral side had subsequently been surgically shortened.3 patients had an affected extremity that was relatively overlength by 1.3 cm (0.5-2.0) on average.9 patients showed differences in the rotation of 10 to 20 degrees during the evaluation of hip mobility.5 patients had restricted motion on hip mobility of more than 20 degrees compared to the contralateral side.1 hip joint had developed partial femoral head necrosis that developed as a late symptom.2 patients had low-grade osteomyelitis that healed after implant removal.2 patients had instability of the intertrochanteric fixation that required revision osteosynthesis.This report is for an unknown ao 90 degrees angled blade plate and screws.It captures the adverse events of moderate radiologic signs of degeneration (arthrosis grade i), restricted motion lesser than 20 degrees, poor results with more distinct radiologic signs of degeneration (arthrosis grade ii/iii), symptoms of limitations of daily activities, functional deficits of more than 20 degrees compared to the contralateral side, slight limping due to shortening, positive trendelenburg sign, residual shortening of the affected extremity, overlength of the affected extremity, 10 to 20 degrees difference in rotation for hip mobility, more than 20 degrees restricted motion on hip mobility, partial femoral head necrosis, low-grade osteomyelitis, implant removed.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS-FEMUR
• 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: 8753623
• MDR Text Key: 149806138
• Report Number: 8030965-2019-65950
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• 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