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

Model Number	33623306
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a revision is needed due to malposition.
Additional 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 or Problem Description
It was reported that a revision is needed due to malposition.

• Brand Name: UNKNOWN INFINITY TIBIAI COMPONENT
• Common Device Name: 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
• Report Number: 3010667733-2022-00448
• Device Sequence Number: 5922485
• Product Code: HWT
• UDI-Device Identifier: 00889797006705
• UDI-Public: 00889797006705
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown