MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

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

Patient Problem Unspecified Infection (1930)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown va lcp condylar plate/ 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.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: müller, m.Et al (2019), the worst-case scenario: treatment of periprosthetic femoral fracture with coexistent periprosthetic infection¿a prospective and consecutive clinical study, archives of orthopaedic and trauma surgery, vol.139 (xx), pages 1461-1470, (germany).The aim of this prospective case series study is to describe eight cases with successful treatment of concomitant pji and ppf with a limb-preserving strategy.Between 2015 to 2016, a total of 8 patients (4 male and 4 female) with a mean age of 77 years (55¿91) were included in the study.Revisions surgery for fracture stabilization was performed using the va-lcp condylar plate (depuy synthes, warsaw, indiana, usa), ao rod and other devices from competitors.After discharge, patients were followed up clinically (mainly for signs of infection persistence) and radiographically every 3 months within the 1st year, then annually.The mean follow-up was 34 ± 8 months.The following complications were reported as follows: a (b)(6) year-old male patient had an acute hematogenous pji involving streptococcus dysgalactiae at the left hip endoprosthesis site after 4 months.Irrigation, debridement, and exchange of modular components were performed immediately.The diagnosis of acute pji originating from the oral cavity was confirmed after a dental assessment revealed severe periodontitis.As a result, sanitation of the patient¿s dental foci was initiated, which had obviously been responsible for the recurrent infections for years.The patient was discharged after 2 weeks of i.V.Treatment and administered with 3 × 1 g amoxicillin for a total of 12 weeks.A (b)(6) year-old female patient had trochanter dislocation and refixation was done by plate osteosynthesis (claw plate with cerclages).This report is for an unknown synthes valcp condylar plate.It captures the reported (b)(6) year-old male patient who had an acute hematogenous pji involving streptococcus dysgalactiae at the left hip endoprosthesis site after 4 months.This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• 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: 10089514
• MDR Text Key: 192155017
• Report Number: 8030965-2020-03709
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 05/13/2020
• 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
• Patient Age: 55 YR