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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.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key8198465
MDR Text Key131473069
Report Number8030965-2018-59263
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
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 Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1