MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - CONSTRUCTS: PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Injury (2348); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: plate/screws /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.

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: kang j., et al (2019) prognostic factors and clinical outcomes after treatment of periprosthetic femoral fractures using a cable-plate, hip pelvis volume 31(3), pages 166-173 (korea, south) http://dx.Doi.Org/10.5371/hp.2019.31.3.166.This study aims to assess clinical outcomes and analyze potential prognostic factors in the treatment of pffs using the cable-plate construct.Between january 2003 and february 2016, a total of 41 patients (41 hips) 20 males and 21 females, with an average age of 67.3±12.1 years (range, 42-86 years of the vancouver type b1 fractures treated by osteosynthesis using the cable-plate construct for fixation were reviewed.The patients were divided into two groups postoperatively.The union group 1 (n=29) with 14 males and 15 females age 069.6±12.4 62.0± years group ii (n=12) with 6 males and 6 females age 62.0±9.7 years the cable ready plate (zimmer, warsaw, in, usa) was used as the cable-plate system in 25 cases.When unicortical proximal locking screws were considered to be available for additional fixation,we used the ao locking compression plate (synthes gmbh, oberdorf, switzerland) in 16 cases with cable fixation of the proximal segment.All cases were treated by cable-plate construct without stem change, including a 10-hole cable-plate (n=17), an 8- hole cable-plate (n=8), a 13-hole locking compression plate (n=6), and an 11-hole locking compression plate (n=10).All previous hip arthroplasty procedures were conducted using a cementless femoral stem.The mean followup period was 31.5±11.6 months (range, 12-58 months).The following complications were reported as follows: healing failure of surgical treatment was observed in 12 cases (group ii), which were a delayed union (n=10) and nonunion (n=2) (fig.3).A case of a 72-year-old female with a vancouver type b1 transverse fracture around or just distal to a well-fixed femoral stem, having severe osteoporosis with bone mineral density ¿4.0, who visited after slip down.Underwent open reduction and internal fixation carried out with cable-plate construct follow-up x-ray 10 months after surgery showing delayed union.(fig.3) this report is for an unknown synthes 13-hole locking compression plate and 11-hole locking compression plate.A copy of the literature article is being submitted with this medwatch.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• 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: 10540558
• MDR Text Key: 215473372
• Report Number: 8030965-2020-07039
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• 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: 08/21/2020
• 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