MAUDE Adverse Event Report: TORNIER INC UNKNOWN FUTURA CONICAL SUBTALAR CSI IMPLANT; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Catalog Number UNK_WTB

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

Patient Problem Swelling/ Edema (4577)

Event Date 09/08/2022

Event Type  Injury  

Manufacturer Narrative

The reported event that the patient required physical therapy due to bone marrow edema could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.     if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The post market clinical team has conducted a follow-up report on ¿radiographic clinical observational study on patients treated for flat foot¿.The study was conducted at 'irccs istituto ortopedico galeazzi, italy'.The report is associated with the stryker ¿futura conical subtalar implant system (csi)¿ and includes an analysis of the clinical data that was collected on 20 patients.The cases in the study range from january 2005 to may 2016.The report indicates that 1 patient experienced a bone marrow edema of the hindfoot after four months from subtalar joint arthroereisis (sta), which was solved with physical therapy.

• Brand Name: UNKNOWN FUTURA CONICAL SUBTALAR CSI IMPLANT
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15546477
• MDR Text Key: 301235858
• Report Number: 0001649390-2022-00077
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• 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): Other