MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: DHS/DCS; APPLIANCE, FIXATION, NAIL

Device Problems Break (1069); Migration (4003)

Patient Problems Pulmonary Embolism (1498); Death (1802); Hematoma (1884); Failure of Implant (1924); Unspecified Infection (1930); Myocardial Infarction (1969); Pain (1994); Sepsis (2067); Thrombosis (2100); Non-union Bone Fracture (2369); Impaired Healing (2378); Bronchopneumonia (2437); Post Operative Wound Infection (2446); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dynamic hip 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: bannister, g.C., gibson, a.G.F., ackroyd, c.E., newman, j.H.(1990), the fixation and prognosis of trochanteric fractures.A randomized prospective controlled trial, clinical orthopaedics and related research, vol.Xx (xx), pages 242-246 (united kingdom).The aim of this randomized prospective controlled study is to confirm the reported mechanical differences in a controlled trial, to identify which fractures might benefit from sliding-screw fixation, and to establish whether the implant had any influence on patient mortality, capacity to return home, or subsequent ability to walk.During 1981, a total of 155 patients (28 male and 127 female) with a mean age of 80 years (range, 65-101 years) were included in the study.Surgery was performed using a 135° ao dynamic hip screw (dhs) or a competitor's device.Patients were reviewed two, four, and 12 months after fracture.The mean follow-up period was unknown.The following complications were reported as follows: 55 patients died.The overall mortality in the series was 26% within three months and 35% within one year.Thirty-six deaths occurred in the hospital and 27 in the community.Bronchopneumonia, myocardial infarction, pulmonary embolism, cerebral thrombosis, malignant tumors, septicemia, and cardiac failure were the causes of death in the hospital.Mortality after one year was 22% if patients lived alone or with minimal assistance before fracture; if they were heavily dependent, it was 52%.1 patient had a deep infection.3 patients had a superficial infection.1 patient had hematoma needed to be evacuated.1 patient had failed to unite.12% of patients receiving the dhs complained of hip pain at 1 year after fracture.74% of all fractures changed position between fixation and union.Of the acute reoperations, one fracture fell into the stable classification.21% of those who could climb stairs or walk 400 m before fracture ultimately deteriorated by two grades.8 out of 50 dhs showed evidence of mechanical failure (if implant migrated within or cut out of the femoral head, bent, broke, or penetrated the acetabulum).In stable fractures, mechanical failure occurred in 18% of dhss and in the unstable group, 15% of dhss.This is report 9 of 9 for (b)(4).This report is for an unknown synthes dynamic hip screw construct.

• Brand Name: UNK - CONSTRUCTS: DHS/DCS
• Type of Device: APPLIANCE, FIXATION, NAIL
• 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: 10240403
• MDR Text Key: 200803818
• Report Number: 8030965-2020-04682
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2020
• 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