MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for UNK - CONSTRUCTS: DHS/DCS manufactured by Oberdorf Synthes Produktions Gmbh.
[188491009]
A total of 90 patients with an average age of 72. 3 years were treated with osteosynthesis by either dynamic hip screw (dhs) or mcs. A total of 33 patients (15 male and 18 female) with a mean age of 70. 1? 5. 2 years were treated with dynamic hip screw (midhs group); 25 patients (12 male and 13 female) with a mean age 74. 6? 4. 1 years were treated with conventional dynamic hip screw (cdhs group); 32 patients (17 male and 15 female) with a mean age 72. 8? 3. 9 years were treated with multiple cannulated screws (mcs group) using three 6. 5-mm (ao) cannulated screws. This report is for an unknown dhs/dcs construct/unknown lot. Part and lot number 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).
Patient Sequence No: 1, Text Type: N, H10
[188491010]
This report is being filed after the review of the following journal article: lee, y. -s. Et al (2008), internal fixation of undisplaced femoral neck fractures in the elderly: a retrospective comparison of fixation methods, the journal of trauma: injury, infection, and critical care, vol. 64 (1), pages 155-162, (taiwan). The aim of this retrospective randomized study is to present the minimally invasive technique and to compare the clinical outcomes of undisplaced femoral neck fractures that were treated with the midhs, or cdhs, or mcs fixation method. Between 1997 to 2004, a total of 90 patients with an average age of 72. 3 years were treated with osteosynthesis by either dynamic hip screw (dhs) or mcs. A total of 33 patients (15 male and 18 female) with a mean age of 70. 1? 5. 2 years were treated with dynamic hip screw (midhs group); 25 patients (12 male and 13 female) with a mean age 74. 6? 4. 1 years were treated with conventional dynamic hip screw (cdhs group); 32 patients (17 male and 15 female) with a mean age 72. 8? 3. 9 years were treated with multiple cannulated screws (mcs group) using three 6. 5-mm (ao) cannulated screws. All patients were followed up retrospectively for at least 12 months to compare the clinical results among the midhs, cdhs, and mcs groups. The average period of follow-up was 25. 5 months (range, 13? 41 months) for midhs, 28. 6 months (range, 12? 62 months) for cdhs, and 30. 3 months (range, 12? 68 months) for mcs. The following complications were reported as follows: midhs group: 3 patients treated with midhs died. 3 patients had mild avn changes (ficat stage ii) but all were pain free. 1 patient (3. 0%) with chronic renal insufficiency had severe avn (ficat stage iii) and underwent hemiarthroplasty. A (b)(6)-year-old male patient had a slight valgus but no evidence of mechanical failure at 2-year postoperative. 4 patients had inadequate screw position. Cdhs group: 2 patients treated with cdhs died. 2 patients had mild avn changes (ficat stage ii) and received nonoperative treatment. 1 patient (4%) had severe avn (ficat stage iii) was treated with hemiarthroplasty. 2 patients had inadequate screw position. 1 of these patients, had avn. Mcs group: 3 patients treated with mcs died. 2 patients showed mild avn changes (ficat stage ii) and received nonoperative treatment. 1 patient had severe avn (ficat stage iii) was treated with hemiarthroplasty. 9 patients had inadequate screw position. 2 of these patients had avn. 3 patients had implant failures because of early screw loosening with a gap of displaced fracture. Hemiarthroplasty was performed on these patients. 1 patient had nonunion and underwent arthroplasty. In this case, an inadequate screw position was shown in the initial radiography. This report is for an unknown dhs/dcs construct. This is report 1 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02229 |
| MDR Report Key | 9873555 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - CONSTRUCTS: DHS/DCS |
| Generic Name | APPLIANCE, FIXATION, NAIL |
| Product Code | KTT |
| Date Received | 2020-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |