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); Unspecified Infection (1930); Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate & screws constructs.Part and lot numbers are unknown; udi 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: ehlinger, m.Et al (2011), periprosthetic femoral fractures treated by locked plating: feasibility assessment of the mini-invasive surgical option.A prospective series of 36 fractures, orthopaedics & traumatology: surgery & research, vol.97 (6), 622-628, doi:10.1016/j.Otsr.2011.01.017 (france).The objective of this prospective study was to evaluate the outcome of periprosthetic femoral fractures in a population of elderly subjects and report the risk of iterative fracture as well as to evaluate the feasibility and role of mini-invasive surgery in preserving the fracture hematoma.A total of 35 patients (28 females and 7 males), ages ranging from 39-93 years (mean age-76 years), with a fracture around the hip implant (21), around the knee (8), between the hip implant and the knee (2), between a trochanteric internal fixation device and the knee implant (5) were included in the study.All patients (one bilateral) were treated between june 2002 to december 2007.The preoperative parker score was 5.25 (0¿9).Internal fixation was performed using large fragment titanium plates and locking screws lcp (synthèstm).A distal anatomical plate was utilized in 27 cases and a diaphyseal anatomical plate in 9 cases.Twenty (20) cases experienced pain after postoperative rehabilitation.Pseudarthrosis was confirmed in one patient and was not treated due to the patient's comorbidities and general condition.One developed staphylococcus aureus hematogenous septic arthritis in the knee 6 weeks after surgery and was treated with antibiotics.Of the 3 mechanical complications, two cases of early fixation failure occurred 3 days and 3 weeks after surgery, respectively.In the first case, revision surgery was done, where the femoral stem was changed.Failure was due to an incorrect indication and conservative internal fixation performed on a type b3 vancouver fracture.In the second case locking plate assembly on the interprosthetic fracture lacked stability.The remaining case was of a plate breakage that occurred 6 weeks after surgery due to poor distribution of the locking screws which were placed near the fracture line.Revision of internal fixation was done.In conclusion, the authors suggest that mini-invasive surgery can be indicated for fractures around non-loosened on prostheses good clinical and radiological results and that locking plates are well adapted to the treatment of these fractures.Indications must be respected for the success of this approach.Procedure: locked plating.Patient(s) info: titanium plates and locking screws lcp (synthèstm), n=20 - pain, n=1 - pseudarthrosis, n=1 - staphylococcus aureus hematogenous septic arthritis, n=3 - mechanical complications, n=2 - early fixation failure, n=1 - plate breakage, n=7 - death.Treatment noted: staphylococcus aureus hematogenous septic arthritis was treated with antibiotics.Plate breakage required revision of internal fixation.One case of early fixation failure required revision surgery, where the femoral stem was changed while treatment for the other case was not provided.Pseudarthrosis was not treated due to the patient's comorbidities and general condition.There was no specific treatment provided for pain.This report is for an unknown synthes plate and screw construct and unknown synthes plate.This complaint involves three (3) device this report is for one (1) unknown plate & screws constructs this impacted product captures the following adverse events: pain.Pseudarthrosis.Staphylococcus aureus hematogenous septic arthritis.This is report 1 of 3 for (b)(4).

• 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: 9416939
• MDR Text Key: 185264971
• Report Number: 8030965-2019-70808
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/14/2019
• 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