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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: PHILOS PLATE, FIXATION, BONE

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SYNTHES GMBH UNK - PLATES: PHILOS PLATE, FIXATION, BONE Back to Search Results
Device Problem Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Date 09/13/2021
Event Type  Injury  
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. 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.
 
Event Description
This report is being filed after the review of the following journal article: cheng h. , et al (2021) treatment of 2-part proximal humeral fractures in osteoporotic patients with medial calcar instability using a philos plate plus an allogeneic fibula inserted obliquely ¿ a retrospective study, geriatric orthopaedic surgery & rehabilitation volume 12: 1¿8, pages 1-8 (china). This retrospective aims to assess the outcomes of elderly individuals with severe osteoporotic 2-part proximal humerus fractures (phfs) combined with medial column (calcar) instability or disruption who were treated with a proximal humeral internal locking system (philos) plate combined with a humeral calcar inserted obliquely using an allogeneic fibula at an angle of 120° to the longitudinal axis of the humerus shaft (an angled allogeneic fibula insertion technique) for maintaining this reduction. One hundred and twelve consecutive elderly individuals sustaining severe osteoporotic 2-part phfs combined with medial column (calcar) instability or disruption were identified from 3 tertiary medical centres from (b)(6) 2014 to (b)(6) 2019. Of 112 patients, 26 (23. 2%) were excluded according to the present criteria, as presented in. Leaving 86 eligible patients from whom all relevant information was available met the inclusion and exclusion criteria. There were 39 men and 47 women. Mean age was 68. 8 ( ± 5. 2) years. The philos plate (synthes, solothurn, switzerland) was used. Follow-ups occurred at 3 months, 6 months and 12 months after surgery and yearly thereafter. Median followup was 24 (15. 3¿27. 6) months. Reported complications: 4 individuals had loss of reduction, 4 experienced postoperative loosening, 1 had non-union, 4 suffered a periprosthetic fracture, 1 had a dislocation related to a malreduction, 5 suffered an unbearable shoulder pain. Revision was mostly attributed to periprosthetic fractures. One case was revised with a reverse total shoulder arthroplasty (zimmer, (b)(4), usa); 2 cases underwent a semi-shoulder joint replacement (trabecular metal; zimmer, (b)(4), usa). 3 experienced a revision surgery which was mainly attributed to postoperative loosening and dislocation. 4 aseptic loosening. This report is for unk - plates: philos. A copy of the literature article is being submitted with this medwatch. This is report 2 of 4 for (b)(4).
 
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Brand NameUNK - PLATES: PHILOS
Type of DevicePLATE, FIXATION, BONE
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 Key15120685
MDR Text Key296757673
Report Number8030965-2022-05318
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2022
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
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/28/2022 Patient Sequence Number: 1
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