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

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

Patient Problems Death (1802); Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

Multiple patients involved this report is for an unk - constructs: dhs/dcs/unknown lot.Part and lot numbers are unknown; udi number is unknown.Implant date: unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: nunn, d.(1988), sliding hip screws and medial displacement osteotomy, journal of the royal society of medicine, vol.81, pages 140-142 (united kingdom).The purpose of this study is to analyze the patient who underwent medial displacement osteotomy using sliding hip screws.A total of 108 patients underwent compression screw fixation of trochanteric fractures of the femur.The mean age was 75.8 years.There were 47 unstable intertrochanteric fractures, 20 of which were treated by a displacement osteotomy.Implant used were how medica compression hip screw at st george's, and ao dynamic hip screw at st james'.The following complications were reported as follows: 5 of the 47 patients died in the follow-up period and 6 were re-operated upon.22 patients had radiological evidence of extrusion of the screw, the factors which correlated with failure being a superior position of the screw in 75% and a low serum albumin in 92%.8 patients in both groups of unstable injuries demonstrated radiological extrusion of the screw.There was a higher incidence of malposition of the screw in both groups; the screw entered the superior third of the head on the anteroposterior view.There were some patients, however, in whom the screw had been correctly positioned and yet still extruded.Measurable collapse of the fractures occurred more frequently in the fixations which failed.5 patients had ultrasonically detected hematomas.These were the 6 of 47 patients that were re-operated.2 patients had major wound infections, and both extruded.The fixation device was removed; 1 subsequently died and the other united with gross coxa vara.1 patient had a total hip replacement at a third operation after removal of the screw led to progressive coxa vara.1 patient had fixation revised with a sarmiento type of osteotomy but died soon after.1 had the device removed for symptomatic extrusion, and again united in gross coxa vara, 1 had the metal removed and underwent a corrective osteotomy and grafting procedure 18 months later for a progressive varus and malrotation deformity.This report is for an unknown synthes ao dynamic hip screw.

• 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: 10397104
• MDR Text Key: 202580116
• Report Number: 8030965-2020-05900
• 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: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• 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: 08/06/2020
• 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): Death