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 Arthritis (1723); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dynamic hip screw (dhs)/ dynamic condylar screw (dcs) construct/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Implant date is between january 1, 2003 to december 31, 2009.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: enocson, a.And lapidus, l.J.(2012), the vertical hip fracture ¿ a treatment challenge.A cohort study with an up to 9 year follow-up of 137 consecutive hips treated with sliding hip screw and anti-rotation screw, bmc musculoskeletal disorders, vol.13 (171), pages 1-6 (sweden).The aim of this cohort study is to analyse risk factors for reoperation of these fractures.Between january 1, 2003 to december 31, 2009, a total of 137 patients (60 male and 77 female) with a mean age of 82.9 years (range 29-98) were included in the study.Surgery was performed using a dynamic hip screw (dhs) with a 2-hole or a 4-hole plate (synthes, west chester, pa, usa).The median follow-up time was 2.3 years (0-8.8) for all cases and 4.8 years (2.2-8.8) for those still alive on december 31, 2011.The following complications were reported as follows: the 6-month mortality was 25% (32/127), and the 1-year mortality was 31% (43/127).1 patient, who did not undergo reoperation, died before postoperative radiographs were obtained.An (b)(6) year-old female patient had a cut out and underwent reoperation (girdlestone) at 11 months.An (b)(6) year-old male patient had a cut out and underwent reoperation (bipolar hemiarthroplasty) at 2 weeks.An (b)(6) year-old female patient had a cut out and underwent reoperation (girdlestone) at 1 month.An (b)(6) year-old female patient had a cut out and underwent reoperation (unipolar hemiarthroplasty) at 6 months.An (b)(6) year-old female patient had a cut out and underwent reoperation (total hip arthroplasty) at 3.5 months.A (b)(6) year-old female patient had a cut out and underwent reoperation (total hip arthroplasty) at 15 months.A (b)(6) year-old female patient had a lateral pain and underwent reoperation (extraction of all implants) at 1.5 years.A (b)(6) year-old female patient had a lateral pain and underwent reoperation (extraction of ars) at 3 years.A (b)(6) year-old male patient had a lateral pain and underwent reoperation (extraction of all implants) at 3 years.A (b)(6) year-old female patient had a lateral pain and underwent reoperation (exchange to shorter screws) at 4 months.A (b)(6) year-old female patient had a lateral pain and underwent reoperation (extraction of all implants) at 2 years.A (b)(6) year-old male patient had a nonunion and underwent reoperation (unipolar hemiarthroplasty) at 7 months.A (b)(6) year-old male patient had a nonunion and underwent reoperation (total hip arthroplasty) at 10 months.A (b)(6) year-old male patient had a nonunion and underwent reoperation (bipolar hemiarthroplasty) at 1 month.A (b)(6) year-old female patient had a nonunion and underwent reoperation (total hip arthroplasty) at 4 months.A (b)(6) year-old female patient had a deep infection and underwent reoperation (extraction of all implants) at 1 year.A (b)(6) year-old male patient had a deep infection and underwent reoperation (girdlestone) at 2 years.A (b)(6) year-old male patient had an avascular necrosis and underwent reoperation (total hip arthroplasty) at 1.5 years.A (b)(6) year-old female patient had an avascular necrosis and underwent reoperation (total hip arthroplasty) at 10 months.A (b)(6) year-old male patient had a subtrochanteric fracture and underwent reoperation (im nail) at 24 days.An (b)(6) year-old male patient had a post traumatic osteoarthritis and underwent reoperation (total hip arthroplasty) at 6 months.This report is for an unknown synthes dynamic hip screw.This report is for one (1) unk - constructs: dhs/dcs.(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: 9349367
• MDR Text Key: 185178768
• Report Number: 8030965-2019-70435
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• 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
• Patient Age: 81 YR