MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VA-LCP; PLATE, FIXATION ,BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.510k: this report is for an unknown va-lcp plate/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between october 2013 to december 2015.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

This report is being filed after the review of the following journal article: volk d, et al.(2021), outcome after polyaxial locking plate osteosynthesis in proximal tibia fractures: a prospective clinical trial, bmc musculoskeletal disorders, volume 22, article number 286, https://doi.Org/10.1186/s12891-021-04158-z (germany).The aim of this study was to evaluate the clinical and/or radiologic outcome using different polyaxial locking plates for the treatment of proximal tibia fractures, the non-contact-briding plate (ncb-pt®) by zimmer or the variable angle locking compression plate (va-lcp®) by synthes.During a period from october 2013 to december 2015, 28 patients aged 25 to 82 who has fracture of the proximal tibia were included in the study.The patients underwent a locking plate osteosynthesis with either the competitor¿s system or the unknown synthes va-lcp system.The implant was chosen according to the surgeon¿s experience and preference.For the patients implanted with the unknown synthes va-lcp system, there were males and 10 females with a mean age of 57.1 years.Postoperative procedure consisted of a partial weight bearing for 6 weeks for all patients.Regarding the allowed range of motion, it was distinguished into two different groups: patient who received an arthrotomy and a refixation of the meniscus ought to comply with a limited range of motion for 6 weeks overall (week 1¿2 30/0/0, week 3¿ 4 60/0/0, week 5¿6 90/0/0, week 7 free range of motion).Patients with no arthrotomy were allowed free range of motion immediately after surgery.Postoperative clinical and radiological follow-ups were conducted after 12 months.Complications were reported as follows: a (b)(6) year-old male patient had valgus deformity after complete bone healing.The patient underwent revision.A (b)(6) year-old female had a deep vein thrombosis (popliteal, fibular, or tibial vein).A (b)(6) year-old female had a deep vein thrombosis (popliteal or superficial femoral vein).A (b)(6) year-old male had a postoperative depression in the dorsal articular surface.The patient underwent revision.This report is for the unknown synthes va-lcp system.This report is for one (1) unknown va-lcp construct.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VA-LCP
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12318633
• MDR Text Key: 266404900
• Report Number: 8030965-2021-06638
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• 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: 07/15/2021
• 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: 61 YR