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

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

Patient Problems Arthritis (1723); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.This report is for unknown quantity of unknown tomofix plate.Part#, lot# and udi # is not available.Implanted, explanted dates:: unknown.Device is not expected to be returned for manufacturer review/investigation.This report is for unknown quantity of unknown tomofix plate.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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: goshima k, et al (2017).Patellofemoral osteoarthritis progression and alignment changes after open-wedge high tibial osteotomy do not affect clinical outcomes at mid-term follow-up.Arthroscopy: the journal of arthroscopic and related surgery.Volume 33.Number 10.Pages 1832-1839.(japan).The purposes of this study were to evaluate the clinical and radiological outcomes of open-wedge high tibial osteotomy (owhto) with respect to the patellofemoral joint and to assess whether patellofemoral oa progression and alignment changes after owhto affect clinical outcomes.53 patients (60 knees) who underwent owhto from march 2005 to september 2013 were included in the study.There were 15 males and 38 females.The mean age at the initial surgery was 61.8 +/- 10.4 years (range, 38-83 years).These patients were implanted with an unknown synthes tomofix plate with 8 locking screws for osteotomy fixation.Full weight bearing was permitted after 4 weeks post-op.The mean follow-up period was 58.2 +/- 22.4 months (range, 25-106 months).The severity of akp was graded using the visual analog scale and scored as follows: 0: no pain, 1 to 3 points: mild, 4 to 6 points: moderate, and 7 to 10 points: severe.Complications were reported as follows: mild anterior knee pain in 2 knees.Patellofemoral joint osteoarthritis progressed in 15 knees.Cartilage degeneration had progressed in 27 knees.Progressive cartilage degeneration was observed at the lateral facet in 15 knees, at the medial facet in 10 knees and at the trochlear grove in 18 knees.This report is for unknown quantity of unknown tomofix plates.This is report 1 of 1 for (b)(4).

• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7635309
• MDR Text Key: 112276451
• Report Number: 8030965-2018-54600
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/25/2018
• 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