MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 90-DEGREE ANGLED BLADE; PLATE, FIXATION, BONE

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

Patient Problems Laceration(s) (1946); Joint Dislocation (2374); Impaired Healing (2378); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown 90° ao blade plate/unknown lot.Part and lot number are unknown; udi number is unknown.Date of implantation is an unknown date between.2008 and 2018.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: pisecky, l.Et al.(2021), results after spica cast immobilization following hip reconstruction in 95 cases: is there a need for alternative techniques?, archives of orthopaedic and trauma surgery, vol.Xx, pages 1-9 (austria).The purpose of this study was to evaluate the short-term outcome after hip reconstruction in patients with developmental dysplasia of the hip (ddh), neurogenic dysplasia of the hip (ndh), and perthes disease.Between 2008 and 2018, a total of 83 patients (40 males and 43 females) with a mean age of 7.95 ± 5.18 years underwent hip reconstructive surgery using a conventional 90° ao blade plate (64 hips) or a 90° locking cannulated blade plate (15 hips).All patients were treated with a spica cast postoperatively for a 6-week protocol.Immobilization in spica cast was administered for a mean of 6.16 weeks, with a range from 5 to 12 weeks and a first standard deviation of 1.1 weeks.The following complications were reported: 7 patients had superficial skin lesions, 3 patients had deep skin lesions, 3 patients had spasticity of adductors, 2 patients had subluxation, 1 patient had infection of the implanted plate, 1 patient had fracture of the plate, 1 patient had a compliance problem, 2 patients had dislocations of the cast, 1 patient had relaxation, 1 patient had delayed bone healing, 1 patient had spasticity of knee flexors.The interventions needed to treat the complications were 5 surgical revisions with three repositions, 2 removals of the plate, 3 inpatient treatments for analgesia and wound care and one admission for high-energy shockwave treatment due to delayed healing of the bone.Four patients needed wound treatment in our outpatient clinic on a continuous basis.This report is for an unknown 90° ao blade plate.This is report 1 of 4 for (b)(4).

• Brand Name: UNK - PLATES: 90-DEGREE ANGLED BLADE
• 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: 12174761
• MDR Text Key: 261751653
• Report Number: 8030965-2021-05774
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• 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: 06/30/2021
• 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