MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LOCKING: PROXIMAL HUMERUS PLATE; PLATE, FIXATION, BONE

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

Patient Problems Joint Contracture (4528); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - plates: locking: proximal humerus plate/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 taiwan as follows: this report is being filed after the review of the following journal article: wei y., lai y., chang w., (2019) anatomic three-dimensional model-assisted surgical planning for treatment of pediatric hip dislocation due to osteomyelitis, journal of international medical research volume 48(2), pages 1¿9 (taiwan) doi: 10.1177/0300060519854288.This study presents a case report of a patient an inexpensive 3d skeletal model (about usd 582.37 in this case) was used as a preoperative surgical guide for skeletal reconstruction.A case of a first-born boy who presented with a limping gait at (b)(6) years of age.Bone changes were detected on radiography and magnetic resonance imaging, with lobulated joint effusion over the right hip joint and peripheral enhancement.A diagnosis of osteomyelitis was made.Due to rapid clinical progression antibiotic administration and surgical intervention were initiated.Six debridement and open arthrotomy procedures were performed.Repeated radiographs showed a proximal femur valgus deformity with lateral subluxation of the right femoral head and posterior angulation of the femoral shaft at the middle third, with a nearly full osseous recovery.The clinical examination and 3d computed tomography (ct) image revealed a genu valgus deformity with flexion and extension deficits.A further corrective surgery for the angulation and rotation was scheduled for the patient.A proximal femur varus derotation osteotomy was carried out to correct the angulation and rotation of the femoral shaft, and a pemberton osteotomy was performed for the residual acetabular dysplasia with lateral subluxation of the right femoral head using a locking proximal humeral plate (depuy synthes, west chester, pa, usa), chosen based on the preoperative simulation.By 3d ct imaging, a more precise osteotomy and implant positioning could be achieved with the help of a life-size model.The osteotomy achieved the best possible bone fixation, the patient was encouraged to start passive joint mobilization and stretching exercises 4 months after the surgery, and he underwent a series of hip spica corrections.We compared the radiological and physical findings before and after the surgery.Osteotomy site union was confirmed during the 15-month follow-up and 3).Because of residual external rotation contracture of the extended hip with toe-out gait, we suggested the use of a twister.Additionally, the leg length discrepancy was <5 mm at the 2-year postoperative follow-up.This report is for an unknown synthes locking proximal humeral plate.This report is for (1) unk - plates: locking: proximal humerus plate.This report is 1 of 2 for (b)(4).

• Brand Name: UNK - PLATES: LOCKING: PROXIMAL HUMERUS PLATE
• 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: 11975800
• MDR Text Key: 267265232
• Report Number: 8030965-2021-04771
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• 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: 05/19/2021
• 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: 4 YR