MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MTP CROSSPLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.The reported event that unk_sel (as reported: mtp cross plate) was alleged of non fusion of the bones could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.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.However, a review of the labelling indicated ¿factors capable of compromising implantation success.Bone pathology, osteoporosis, bone tumors, systemic or metabolic problems and infectious diseases.Senility, mental illness, abuse of illegal drugs, prescription drugs or alcohol.Excess weight, intense professional or sporting physical activity that exposes the implant to excessive or repeated loads.Risk of conflict with other implants.Risk of articular conflict.¿ it is recommended that ¿the physician¿s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment.Conditions presenting an increased risk of failure include: any active or suspected latent infection or marked local inflammation in or about the affected area.Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation of the devices.Obesity.An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to failure of the device itself.Patients having inadequate tissue coverage over the operative site.¿ the rmf considers that ¿significant implant failures would typically result in loss of fixation with an increased risk of infection, delayed union, non-union, mal-union and motor loss.¿ and that ¿this is a typical problem of all locking or non-locking plates and with current materials and plate designs there is no potential for further mitigation of the risks?¿ device is not available to stryker.

Event Description

The podiatrist, reported that the patient had pain and non-union following a 1st mpj arthrodesis with a stryker mtp cross plate leading to revision surgery.This patient was notified to stryker following a review of 1st mpj arthrodesis non-union rates in patients treated at (b)(6) hospital (b)(6) between 2010 and 2017 which aimed to explore the relationship between factors associated with non-union.

• Brand Name: UNKNOWN MTP CROSSPLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7539666
• MDR Text Key: 109101057
• Report Number: 0008031020-2018-00399
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention