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

Catalog Number UNK_WWA

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

Patient Problems Ossification (1428); Insufficient Information (4580)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to loose infinity tibial component.The physician would like to revise both the tibial and talar components in order to preserve as much of the patient's bone as possible.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to loose infinity tibial component.The physician would like to revise both the tibial and talar components in order to preserve as much of the patient's bone as possible.

Manufacturer Narrative

Correction - h6 (clinical signs code, results code and conclusion code).The reported event could be confirmed based on available medical record and medical expert assessment.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed "the talar component shows a little radiolucence as well and there seems some condensed bone.However, there is also some artefacts which complicates the assessment.However, the surgeon does not report any loosening and therefore, with the given information, the component has to be assessed as being stable." based on the investigation, the root cause was attributed to a patient related issue.The failure was detected due to some radiolucency and condensed bone around the talar component.With the given information no loosening/migration can be confirmed and hence the component is assessed as stable according to the medical assessment by the hcp.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN INFINITY TALAR 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: 18510691
• MDR Text Key: 332880696
• Report Number: 3010667733-2024-00014
• 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: 03/08/2024

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: 12/19/2023
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 03/08/2024
• 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 Age: 55 YR
• Patient Sex: Male