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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Necrosis (1971); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2021. This report is for an unknown philos plate and screws/unknown lot. Part and lot numbers are unknown; udi 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.
Event Description
This report is being filed after the review of the following journal article: furuhata, r. Et al. (2021), risk factors and prognosis of humeral head inferior subluxation in proximal humeral fractures after osteosynthesis, jses international, vol. 5, pages 739-744 ((b)(6)). This study aimed to clarify the predictive factors that affected the onset of postoperative inferior subluxation using multivariate analysis and examine the postoperative course of inferior subluxation and its influence on postoperative outcomes. Between january 2008 and december 2019, 212 patients who underwent osteosynthesis for neer 2- or 3-part proximal humeral fractures were reviewed. There were 141 females and 71 males with a mean age was 66. 6 ± 15. 8 years (range, 22-95 years). Osteosynthesis, using a locking plate or imn, was performed via the deltopectoral approach or deltoid-split approach, the decision of which was left at the discretion of the surgeon. The plate fixation was performed using a philos plate (depuy synthes, (b)(6)) and 3 other competitor's devices. The imn fixation was performed using a multiloc proximal humeral nail (depuy synthes, (b)(6)), expert proximal humeral nail (depuy synthes, (b)(6)) and 4 other competitor's devices. Based on the presence of inferior subluxation at 1week after the surgery,we divided the patients into two groups:with inferior subluxation (+is group) and without inferior subluxation (-is group). We compared the postoperative outcomes (incidence of postoperative complications and range of motion) between these two groups. The article did not specify which of the devices were being used to capture the following complications: 64 patients showed humeral head inferior subluxation immediately after the surgery (+is group). 3 patients in the +is group and 9 in the -is group had delayed union. 2 patients (+is
1; -is
1) showed asymptomatic nonunion. None of the asymptomatic patients underwent an additional surgery. 5 patients (+is
1; -is
4) had asymptomatic avascular necrosis. None of the asymptomatic patients underwent an additional surgery. 11 patients (+is
5; -is
6) had screw cutout, 4 underwent implant removal, and the screw was retained in 7 asymptomatic cases. 2 patients (+is
1; -is
1) had infection, among which 1 underwent debridement and the implant was removed in the other. 7 patients in +is and 10 patients in -is had fixation failure. 15 patients in +is and 20 patients in -is had reduction loss >10°. 6 patients who had persistent humeral head inferior subluxation at 6 months after surgery also had it at 1 year after the surgery. An elevation of 122 ± 23° and er of 50 ± 22° was also observed among the six patients. The following patients are: a (b)(6) male patient (with unknown plate) had varus angulation/progression from 2 months after surgery. A (b)(6)female patient (with unknown plate) had varus angulation/progression from 3 months after surgery. A (b)(6) male patient (with unknown plate) had an implant removal at 6 months after surgery owing to screw joint perforation. The patient also had varus progression and nonunion at 1 yr after surgery. An (b)(6) female patient (with unknown plate). A (b)(6) female patient (with unknown plate) had varus angulation/progression from 1 month after surgery. A (b)(6) female patient (with unknown imn). This report is for an unknown synthes philos, multiloc and expert. A copy of the literature article is being submitted with this medwatch. This is report 3 of 4 for (b)(4). This report is for an unknown philos plate/screws.
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
MDR Report Key14052377
MDR Text Key288872218
Report Number8030965-2022-02297
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
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 Received03/09/2022
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: 04/08/2022 Patient Sequence Number: 1