MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PLATE, FIXATION, BONE

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

Patient Problems Necrosis (1971); Osteolysis (2377)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown synthes angle-stable plate proximal humeral internal locking system (philos)/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: giardella, a.Et al (2017), reverse total shoulder versus angular stable plate treatment for proximal humeral fractures in over 65 years old patients, muscles, ligaments and tendons journal, vol.7(2), pages 271-278 ((b)(6)).The purpose of this retrospective study is to compare and analyze clinical and radiological outcomes of three- and four- part proximal humeral fractures in two groups of patients older than 65 years, the first treated with orif, the second with rsa.Between january 2009 and october 2014, a total of 44 female elderly patients with a mean age of 73.2 years (range, 65-91 years) were included in the study.These patients were divided into two groups: one group consisted of 23 female operated with open reduction and internal fixation (orif) by angle-stable plate proximal humeral internal locking system (philos) (phlp-synthes, (b)(4)) and one group consisted of 21 female operated with a reverse total shoulder arthroplasty (rsa) (competitor¿s device).The median number of months of follow-up was 28 months (range, 12-84 months) totally, respectively 24 (12-84) months for rsa and 40 (12-66) months for orif.The minimum follow-up was 12 months.The following complications were reported as follow: 2 shoulders had a partial reabsorption of greater tuberosity and 1 of the lesser.1 humeral heads went to partial necrosis.7 patients died were excluded from the study.This report is for partial reabsorption of greater tuberosity and partial necrosis this report is for an unknown synthes angle-stable plate proximal humeral internal locking system (philos).This is report 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: PLATE, FIXATION, BONE
• 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: 8198465
• MDR Text Key: 131473069
• Report Number: 8030965-2018-59263
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• 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: 12/03/2018
• 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