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

Device Problem Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369); Joint Dislocation (2374); Physical Asymmetry (4573); Insufficient Information (4580)

Event Date 09/13/2021

Event Type  Injury  

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 january 2014 to december 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, (b)(4)) 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)); 2 cases underwent a semi-shoulder joint replacement (trabecular metal; zimmer, (b)(4)).3 experienced a revision surgery which was mainly attributed to postoperative loosening and dislocation.4 aseptic loosening.This report is for unk - plates: philos.This is report 1 of 4 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 device/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.

• Brand Name: UNK - PLATES: PHILOS
• Type of Device: PLATE, 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 Key: 15120681
• MDR Text Key: 296759755
• Report Number: 8030965-2022-05316
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• 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
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/28/2022
• 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