MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA; FILLER, BONE VOID, CALCIUM COMPOUND

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

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - biomaterial - preformed: chronos: trauma/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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 korea, south reports an event as follows: this report is being filed after the review of the following journal article: jung w., takeuchi r., kim d., nag r.,(2020) faster union rate and better clinical outcomes using autologous bone graft after medial opening wedge high tibial osteotomy, knee surgery, sports traumatology, arthroscopy volume 28, pages 1380¿1387 (korea, south) this study aims to assess radiological bone union rates and clinical outcomes between three different gap filling options in mow-hto using the tomofix¿ plate.From january 2014 to february 2017, surgery was performed on 280 knees that underwent mow-hto procedure.Among them, 137 knees , 126 patients were included in this study.The patients were grouped into three groups.Group a (n = 46 knees) with 43 patients (34 females, 9 males) age 59.6 ± 7.8 years, gap was filled by ¿-tcp ( chronos® wedge, semicircular; synthes, solothurn, switzerland); group b (n = 48 knees) with 43 patients (34 females,9 males) age 61.5 ± 7.6 years, no gap fillers; and group c (n = 43 knees) with 40 patients (32 females, 8 males) age 60.7 ± 9.3 years , gap filled with ¿-tcp and autologous cancellous bone graft obtained from the ipsilateral medial femoral condyle.The osteotomy was stabilized using a tomofix¿ plate(synthes, oberdorf, switzerland).The patients were followed-up at a mean period of 22 months (ranging from 13 to 49 months).The following complications were reported as follows: 1 patient died who was excluded in the study.(group b).Delayed union: 26 in group a , 20 in group b and 1 in group c.The incidence of lateral cortical hinge fracture was similar in all three groups.Post-operative lateral cortical fracture : 7 in group a, 5 in group b and 9 in group c.Infection: 1 in group a, and 2 in group b.Fig.4 six-month postoperative x-rays and ct scan of (b)(6) year old female who underwent bilateral mow-hto.X-rays show sclerotic rim in left knee which is absent in right.Ct scan shows the absence of bridging callus formation in left knee.This report is for an unknown synthes chronos® and tomofix¿ plate.

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: TRAUMA
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• 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: 11148468
• MDR Text Key: 227777605
• Report Number: 8030965-2021-00213
• Device Sequence Number: 1
• Product Code: MQV
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention