MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX ELBOW DISTAL HUMERUS PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problems Mechanical Problem (1384); Loss of Osseointegration (2408)

Patient Problem Injury (2348)

Event Date 08/01/2009

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf report from (b)(6), us.The title of this report is ¿a retrospective data collection treatment of elbow fractures with the variax elbow plating system¿ which is associated with the stryker variax elbow plating system.Within that publication, postoperative complications/ adverse events were reported which occurred from august 2009 until december 2018.It was not possible to ascertain specific device catalog or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 15 complaint was initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses failure of fixation.The pmcf states: "the other patient had failure of fixation.This was a c3 fracture in an osteoporotic 92 year old smoker.In retrospect, the patient would probably have been optimally treated with a total elbow replacement as the index procedure.She was ultimately converted to a total elbow replacement and did well with this.".

Manufacturer Narrative

Correction in section h6 (device code).

Event Description

The manufacturer became aware of a pmcf report from cedars sinai, new york, us.The title of this report is ¿a retrospective data collection treatment of elbow fractures with the variax elbow plating system¿ which is associated with the stryker variax elbow plating system.Within that publication, postoperative complications/ adverse events were reported which occurred from august 2009 until december 2018.It was not possible to ascertain specific device catalog or patient details from the study, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 15 complaint was initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses failure of fixation.The pmcf states: "the other patient had failure of fixation.This was a c3 fracture in an osteoporotic 92 year old smoker.In retrospect, the patient would probably have been optimally treated with a total elbow replacement as the index procedure.She was ultimately converted to a total elbow replacement and did well with this.".

• Brand Name: UNKNOWN VARIAX ELBOW DISTAL HUMERUS PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9503628
• MDR Text Key: 187943079
• Report Number: 0008031020-2019-02297
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention