MAUDE Adverse Event Report: STRYKER GMBH L-PLATE, LEFT; PLATE, FIXATION, BONE

Model Number 40-15091

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

Patient Problems Injury (2348); Reaction (2414)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

The reported event could be confirmed.A picture of the affected foot was provided.Indeed, black deposits were noticed on the soft tissues especially on the distal part.The l plate as the screws that were implanted with it were returned after decontamination, and do no present any deformation, breakage or such.No deposits can be noticed anymore, since it was decontaminated.In this case, the expertise of a medical expert was requested.They stated the following; "[.] the literature talks about the varying corrosive effects of anodized titanium, relating to the thickness and color of the anodized layers.At a fracture site, wolff¿s law is occurring with a generation of an electrical current, although very slight, the current occurs within the solutions around the plate and soft-tissue and will corrode to metal surface.It is the interaction of an inorganic material in titanium plates, and soft tissue and he degree of roughness of the implant surface, the methods utilized in achieving the surface topography, and the chemistry of implant materials (titanium), are some of the factors that may affect the soft tissue response of the plate to the adjacent soft tissue and create the grayish color.There has been no risk reported with this corrosive action since the levels of local metal ions and systemic ions is usually at very low levels in these cases.In case of high levels of metal ions, risks have been reported associated with local soft tissue damage, delayed hypersensitivity reaction (type iv) and systemic toxicity.[.]" this case can thus be classified as patient factors related.It can be explained by how the patient reacted to the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

Variax foot plate metallosis noticed upon removal on (b)(6) 2019 by surgeon.Implanted on (b)(6) 2019.Removal not for non-union, just removal of metalware.

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

Variax foot plate metalosis noticed upon removal on (b)(6) 2019 by surgeon.Implanted on (b)(6) 2019.Removal not for non-union, just removal of metalware.

• Brand Name: L-PLATE, LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9549149
• MDR Text Key: 181811114
• Report Number: 0008031020-2020-00060
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154627998
• UDI-Public: 07613154627998
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K063875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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 Model Number: 40-15091
• Device Catalogue Number: 40-15091
• Device Lot Number: 1000352948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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
• Patient Age: 29 YR