MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CEMENT: TRAUMACEM; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Device Problem Migration (4003)

Patient Problems Necrosis (1971); No Code Available (3191)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown traumacem v +/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: knierzinger d., crepaz-eger u., hengg c., kralinger f., (2020) does cement augmentation of the screws in angular stable plating for proximal humerus fractures influence the radiological outcome: a retrospective assessment, archives of orthopaedic and trauma surgery, pages 1-9 (austria).This retrospective study aims to evaluate and analyse the radiological outcome of phfs treated with angular stable plates and additional screw-tip augmentation in patients over the age of 60.Between june 2013 and december 2016, a total of 24 patients (21 females,3 males) at a median age of 77.5 (62¿96) years who suffered from a proximal humerus fractures (phf) treated with angular stable plates and additional cement augmentation of the screws were enrolled in the study.Philos® standard angular stable plates were used for all fractures (depuy synthes companies, zuchwil, switzerland).The screws, which were determined as safe (no intraarticular leakage), were augmented with 0.5 ml cement (traumacem v + ®, depuy synthes companies, zuchwil, switzerland).The median radiological follow-up was at least 12 (6¿42) months.The following complications were reported as follows: primary screw perforation with subsequent small amounts of intraarticular cement (not causing any severe erosion on the joint) was observed in three patients (2 of them had head-split fractures) at the postoperative radiographic follow-ups.At two patients the screw perforation was detected at the c-level and once at the e-level of the angular stable plate.Two of these three patients developed an avn later on.The second case (fig 2 d-g) shows the only secondary fracture displacement (head fragment displaced) in this study with subsequent secondary screw perforation.Revision surgery with the application of reverse shoulder arthroplasty was necessary.In total four patients developed an avn, two of them within 1 year and the other two after 2 years.Revision surgery was indicated in three patients, who developed an avn, twice using hemiarthroplasty by anatomically healed tuberosities and once using reverse shoulder arthroplasty due to an extended rotator cuff lesion.One patient sustained an early secondary displacement (retrotorsion of the head fragment) 7 weeks after surgery.Three months after index surgery revision was indicated using reverse total shoulder arthroplasty.Further secondary displacements, especially varus-displacements, were not observed.Anatomical reduction was not achieved in 12 patients out of 24.Medial hinge restoration was not obtained in 9 patients out of 24.The median head shaft angle was intraoperative 130.5° (115°¿139°) and did not increase or decrease compared to the cured fracture situation (129.5° [111°¿137°]).Fracture healing was obtained in 20 patients out of 21 (95.2%) 3 months after surgery, excluding the 3 patients, who had to undergo an early revision surgery.(fig 1)a case with an accurate calcar restoration and adequate reattached tuberosity to the head fragment (each marked with an arrow) but with a varus mal-reduction this report is for an unknown synthes traumacem v +.It captures the reported events 3 patients who had primary screw perforation with subsequent small amounts of intraarticular cement.Two of these three patients developed an avn later on.The second case (fig 2 d-g) shows the only secondary fracture displacement (head fragment displaced).This is report 2 of 5 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: TRAUMACEM
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• 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: 10374042
• MDR Text Key: 209200870
• Report Number: 8030965-2020-05692
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• 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: 08/03/2020
• 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
• Patient Outcome(s): Required Intervention