MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PHILOS PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Failure of Implant (1924); Necrosis (1971); Nerve Damage (1979); Pain (1994); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 08/31/2021

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.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.

Event Description

This report is being filed after the review of the following journal article: da silva, t.Et al.(2022), protective and risk factors for humerus head necrosis after proximal humerus fracture treated with internal locking plate, indian journal of orthopaedics, vol.56, pages 429-436 (germany).In this retrospective study, we assessed 305 cases of phf with head involvement and analyzed possible protective and risk factors for head necrosis.Between 2008 and 2018, a total of 305 patients with primary traumatic fracture of the proximal humerus with head involvement underwent surgical restoration using a philos (proximal humerus internal locking system¿depuy synthes) plate.The mean follow-up time was 467 days and 64% of the patients had a follow-up greater than 1 year.The following complications were reported as follows: iatrogenic malposition (n=4), infection (n=5), nonunion (n=10), head necrosis (n=4), motor deficit/impingement (n=13), iatrogenic nerve lesion (n=1), omarthrosis/pain (n=13), post-op conversion to prothesis (n=9), cut out/screw dislocation (n=18), plate/screws break (n=1).This report is for unk - constructs: philos plate/screws.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PHILOS PLATE/SCREWS
• 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: 15115600
• MDR Text Key: 296759347
• Report Number: 8030965-2022-05294
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

• Date FDA Received: 07/27/2022
• 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: 06/29/2022
• 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