MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN INBONE POLY COMPONENT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problem Naturally Worn (2988)

Patient Problems Osteolysis (2377); Insufficient Information (4580)

Event Date 07/11/2023

Event Type  Injury  

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.

Event Description

The digital stryker prophecy team received a ct scan indicating that a revision surgery wil be prompted by talar osteolysis due to presumed poly wear.The plan involves converting inbone talus to invision talus with talar platform.Additionally, a change to a vitamin e poly tibial liner (umpwe) is intended, while no revisions are planned for the metal tibial tray or intra-medullary components.

Event Description

The digital stryker prophecy team received a ct scan indicating that a revision surgery wil be prompted by talar osteolysis due to presumed poly wear.The plan involves converting inbone talus to invision talus with talar platform.Additionally, a change to a vitamin e poly tibial liner (umpwe) is intended, while no revisions are planned for the metal tibial tray or intra-medullary components.

Manufacturer Narrative

The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.Upon further investigation of the ct scans by healthcare professionals the following was observed "there is no clear radiolucence around the tibial component.A cavity is visible, which is not necessarily indicating loosening or migration.The pe cannot be assessed directly, however, there is no indirect sign of loosening or dislocation.The talar component shows radiolucence and some cysts.Loosening is likely, migration cannot be confirmed." more detailed information about the complaint event as well as patient history must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN INBONE POLY COMPONENT
• 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: 17479624
• MDR Text Key: 320610240
• Report Number: 3010667733-2023-00430
• 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: 11/17/2023

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: 07/11/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/17/2023
• 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