MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN_WRIGHT MEDICAL-ARLINGTON_PRODUCT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problems Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Insufficient Information (3190); Migration (4003)

Patient Problems Cyst(s) (1800); Joint Dislocation (2374); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 06/30/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a report that a revision surgery is needed for reasons unknown.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in the patient.

Manufacturer Narrative

Please note the correction made to the h6 (results, conclusion & health impact code): the reported event was confirmed since images of ct scans were provided and shows loosening and migration of the tibial component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the tibial component shows severe radiolucence, there are also cysts, both indicate loosening.It is dislocated posteriorly and separated from the respective talar component, therefore we have migration and luxation/separation from the talar component.The pe seems to be in place attached to the tibial component but as the whole talar component/talus/foot is luxated anteriorly, an x-ray could give more information, here.The talar component has a little bit of radiolucence, however, this would not be sufficient to confirm loosening.There are also no signs of migration of the component.¿ based on investigation, the root cause was attributed to a patient related issue.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

The digital stryker prophecy team received a report that a revision surgery is needed for reasons unknown.

• Brand Name: UNKNOWN_WRIGHT MEDICAL-ARLINGTON_PRODUCT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17401643
• MDR Text Key: 319830077
• Report Number: 3010667733-2023-00409
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/20/2023

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: Not provided
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/23/2023
• Supplement Dates FDA Received: 10/20/2023
• 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): Other
• Patient Sex: Female