MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INFINITY TIBIAI COMPONENT; TEMPLATE

Model Number 33623306

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that a revision is needed due to malposition.

Manufacturer Narrative

Please note the correction of the d1, d4 catalog, d9/h3.The complaint could be confirmed, since the returned information for evaluation matches the alleged failure, although the product wasn't returned for evaluation.Medical profession reviewed the received information and noted: the x-ray suggests that the initial alignment was already in varus.There is some radiolucency around the talar dome, may be indicative of beginning of loosening.X-ray not of medical grade, yet talus looks relatively white, suggests osteonecrosis (also some over projection of the fibula over the talus that makes interpretation more difficult.Additional information from sales representative received: the patient got revised, as the primary infinity implants got implanted in varus of 13°, based on a user related issue.All primary tar implants got revised, otherwise it could not be ensured that the alignment will be correct.All primary tar implants were discarded after the revision, no notes about item and lot numbers available.There is no information that this was also a patient or device related issues.No further information is available.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a use related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device discarded.

Event Description

It was reported that a revision is needed due to malposition.

• Brand Name: UNKNOWN INFINITY TIBIAI COMPONENT
• Type of Device: TEMPLATE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15972693
• MDR Text Key: 305417114
• Report Number: 3010667733-2022-00448
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00889797006705
• UDI-Public: 00889797006705
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33623306
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• 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