MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN BIOFOAM WEDGE; PLATE, FIXATION, BONE

Catalog Number UNK_WWA

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

Patient Problem Implant Pain (4561)

Event Date 04/28/2023

Event Type  Injury  

Event Description

A review of study report of retrospective data collection intended to collect safety and performance on subjects that have been previously implanted with the ¿biofoam wedge system' revealed that, ¿one patient had persistent pain, at the first cuneiform bone, that was solved with wedge removal after 1 year and substituted with a bone graft.During the revision surgery the metallic wedge appeared too laterally positioned with an impingement with the central cuneiform bone.However, the metallic wedge was stable and well-integrated and the patient at the last follow up was pain free and satisfied by the procedure¿.

Manufacturer Narrative

The reported event regarding persistent pain that was solved with wedge removal after 1 year and substituted with a bone graft 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.H3 other text : device disposition unknown.

• Brand Name: UNKNOWN BIOFOAM WEDGE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16957137
• MDR Text Key: 315528926
• Report Number: 3010667733-2023-00257
• Device Sequence Number: 1
• Product Code: HRS
• 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: 05/18/2023

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_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/18/2023
• 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