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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Necrosis (1971); Nerve Damage (1979); Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

Device report from synthes reports an event in spain as follows: this report is being filed after the review of the following journal article: foruria a.M., at al (2021) proximal humeral fracture locking plate fixation with anatomic reduction, and a short-and-cemented-screws configuration, dramatically reduces the implant related failure rate in elderly patients, jses international volume 5 pages 992-1000 (spain).This study aims to compare the rate of implant failure after locking plate fixation of complex proximal humerus fractures (phf) using cement augmentation of humeral head screws vs.Plate fixation without cement.Between 2009 and 2019, a total of 190 plate osteosynthesis were performed.22 patients were excluded.The resultant 168 cases form the basis of this retrospective comparative cohort study.A total of 168 open reduction and internal fixation with locking plates were performed for complex proximal humerus fractures by a single surgeon in 136 women and 32 men older than 65 years of age (average 76 years).Cement augmentation for locking plates (trauma cem vþ; depuy synthes) was commercially available in march 2014 and was routinely implemented after that date.Patients were divided into two different treatment groups: group 1 with non-cemented screws (n =90) and group 2 with screw cement augmentation (n =78).Fracture fixation was achieved by a proximal humeral interlocking plate system (philos; depuy synthes, zuchwil, switzerland).The mean follow-up was 33 ± 26 months.The following complications were reported as follows: 7 nonrelated deaths.Twenty-seven (16 group 1 and group 2) patients died after surgery by nonrelated causes.8 implant failure.The most common complication in group 1 was implant failure ,with 8 cases of loss of reduction without screw penetration.5 global avascular necrosis.Plate removal was performed in 1 case.3 peri-implant fracture.One case of peri-implant fracture was treated with plate removal, close reduction, and intramedullary nail fixation, while the other two cases were treated conservatively.1 nonunion.1 axillary neuropathy.In group 1, plate removal was performed in 2 cases of loss of fixation and fracture collapse.Cemented , group 2 1 implant failure.3 global avascular necrosis.Plate removal was performed in 1 case.While conversion to rsa was necessary in 1 case of global avascular.Necrosis.1 pseudoparalysis with rotator cuff tear.3 cement-related partial avascular necrosis.Rsa was necessary in 1 case.Implant failure, 8 cases of loss of reduction with screw penetration.(noncemented, group 1).Implant failure, 1 case of screw back-out and loss of fixation.(noncemented, group 1) 5 plate subacromial impingement.Plate removal was performed in 4 cases.(noncemented, group 1).4 plate subacromial impingement.Plate removal was performed in 4 cases.(cemented group 2).We observed 9 cases of cement extrahumeral location, without any apparent effect in outcome in any of the cases, in group.All cement extravasations were seen in relation with calcar cemented screws in row e.This report is for unknown synthes trauma cem vþ.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown biomaterial - cement: traumacem/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.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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: TRAUMACEM
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14675868
• MDR Text Key: 294779585
• Report Number: 8030965-2022-03924
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• 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: 05/30/2022
• 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