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

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

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Failure of Implant (1924); Unspecified Infection (1930); Skin Irritation (2076); Non-union Bone Fracture (2369); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes condylar locking compression plate (lcp) 4.5/5.0mm plate/screw construct/unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: karam, j., campbell, p., david, m., and hunter, m.(2019), comparison of outcomes and analysis of risk factors for non-union in locked plating of closed periprosthetic and non-periprosthetic distal femoral fractures in a retrospective cohort study, journal of orthopaedic surgery and research, vol.14 (150), pages 1¿10 (australia).The aim of this single-center, retrospective cohort study is to compare the outcomes of surgical treatment, specifically locked plating, of periprosthetic and non-periprosthetic fractures.The secondary aim was to determine predictors of non-union and union in both groups.Between 2011 to 2018, a total of 125 patients were included in the study.68 patients (11 male and 57 female) with a mean age of 80.1 year had periprosthetic fractures and 57 patients (13 male and 44 female) with a mean age of 70.9 years had non-periprosthetic fractures.All patients received locking plate fixation using the stainless-steel condylar locking compression plate (lcp) 4.5/5.0 (depuy synthes, oberdorf, switzerland).Follow up took place at 2 weeks, 6 weeks, 3 months, and 6 months.All patients were followed up for a minimum of 3 months (range 3¿89 months, 22 months mean follow up).The following complications were reported as follows: periprosthetic fracture group: 15 patients died.5 patients had plate failure.4/5 patients were associated with nonunion.1 patient had infection.2 patients had deep vein thrombosis.2 patients had pseudoaneurysm formation.9 patients required revision surgery due to nonunion (n=8) which required revision fixation with bone graft in 4 and distal femoral replacement in another 4 patients, and due to tibial component loosening (n=1).An (b)(6) year old female patient had nonunion which required revision to retrograde nail and graft.A (b)(6) year old female patient had nonunion which required revision to distal femoral replacement.An (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion which required revision to retrograde nail and graft.A (b)(6) year old female patient had nonunion.An (b)(6) year old male patient had nonunion which required revision to distal femoral replacement.A (b)(6) year old male patient had nonunion which required revision to plate and graft.An (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion which required revision to distal femoral replacement.A (b)(6) year old female patient had nonunion.Non-periprosthetic fracture group: 15 patients died.4 patients had plate failure.2/4 patients were associated with nonunion.2 patients had infection.2 patients had symptomatic hardware prominence requiring removal.1 patient had peri-implant fracture.8 patients required revision surgery due to nonunion (n=3) which required revision fixation with bone graft in 2 and distal femoral replacement in 1, peri-implant fracture (n=1), infected nonunion (n=1), and progression of osteoarthritis (n=3).A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion.A (b)(6) year old male patient had nonunion which required revision to arthrodesis.A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion which required revision to plate and graft.An (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion.A (b)(6) year old female patient had nonunion which required revision to distal femoral replacement.A (b)(6) year old male patient had nonunion which required revision to retrograde nail and graft.An (b)(6) year old female patient had nonunion.This is report 1 of 9 for (b)(4).This complaint is linked to (b)(4).This report is for an unknown synthes condylar locking compression plate (lcp) 4.5/5.0mm plate/screw construct.

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• 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: 10741420
• MDR Text Key: 216658655
• Report Number: 8030965-2020-08187
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2020

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: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• 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