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

This report is for an unknown dynamic hip screws/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: thaler hw, et al.(2001), thromboprophylaxis with 60 mg enoxaparin is safe in hip trauma surgery, the journal of trauma injury, infection, and critical care, volume 51, page 518-521, (austria).The aim of this study was to investigate the safety of thromboprophylaxis with low-molecular-weight heparin (enoxaparin) and to determine the incidence of clinically apparent deep vein thrombosis and pulmonary embolism in hip trauma patients treated with low-molecular-weight heparin (lmwh).From january 1997 to february 1999, 946 patients with hip fractures were recruited for perioperative thromboprophylaxis with 60 mg enoxaparin.739 of the treated patients were women (mean age, 82 years; range, 19¿101 years) and 207 were men (mean age, 71 years; range, 21¿97 years).49 patients were not operated on, mainly because of nondislocated (impacted) femoral neck fractures while 875 patients were operated on and received enoxaparin.The operated patients received enoxaparin according to the following regimen: preoperative heparinization from time of admission onwards.Administration of 60 mg enoxaparin, in two doses (20 and 40 mg subcutaneously), during the first 5 days postoperatively.Prophylaxis for a minimum of 5 weeks (40 mg daily).296 of these patients underwent stabilization with the use of unknown synthes dynamic hip screw while the rest of the patients were stabilized using competitors¿ devices.Average duration of hospital stay was 21 days in women (range, 1¿213 days) and 17 days in men (range, 1¿76 days).The duration of follow-up was at least 5 weeks in 97.5 percent of the patients.Complications were reported as follows: 37 patients had clinical signs of deep vein thrombosis.42 patients had major hemorrhage.1 patient had intracerebral bleeding at 12 days after operation.1 patient had intracerebral bleeding that occurred because of new injuries to the head during hospitalization.2 patients had subdural hematomas that occurred because of new injuries to the head during hospitalization.196 patients had wound hematoma of which 20 of them needed surgical evacuation, mostly in patients with septicemia.5 patients had gastrointestinal bleeding because of stress ulcers.1 patient died from hemorrhage caused by an intracerebral event at 16 days after the operation.71 patients died during observation.42 women (mean age, 88 years; range, 75¿101 years) and 29 men (mean age, 80 years; range, 60¿95 years).The cause of death was massive stroke in 7 patients (1 hemorrhage, 6 ischemic strokes, as proven by ct scan), ischemic heart disease in 10, pneumonia in 10, acute renal failure in 10, terminal malignant tumor in 15, and wound infection with septicemia-related multisystem organ failure in 19 patients.4 patients died suddenly and unexpectedly from acute myocardial infarction.This report is for an unknown synthes dynamic hip screws.It captures the reported death of 19 patients who died of wound infection with septicemia-related multisystem organ failure.This is report 2 of 2 (b)(4).

• 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: 10333766
• MDR Text Key: 200654221
• Report Number: 8030965-2020-05342
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• 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: 07/22/2020
• 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