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

Catalog Number UNK_WWA

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)

Patient Problems Cyst(s) (1800); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 11/06/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to possible loosening, poor implant position and persistent pain.

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.H3 other text : device remains implanted in patient.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to possible loosening, poor implant position and persistent pain.

Manufacturer Narrative

Correction - h6 (device 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.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 radiolucence, some small cavities and a little subsidence anteriorly visible in the ct scan for the tibial tray.Loosening and migration can thus be confirmed.The pe is not visible directly in the ct scan, but there is no indirect sign of loosening or breakage.The talar component also shows some radiolucence and some cysts and it seems also depressed laterally, therefore loosening and migration can be confirmed." based on investigation, the root cause was attributed to a patient related issue.The failure was detected by the formation of small cavities and cysts around the tibia and talar component respectively, this resulted in migration and loosening of the implant.Also, a poor positioning of the implant is mentioned by the hcp and may have somehow contributed to the failure, but this could not be confirmed hence, a patient related factor has to be assumed as the underlying cause.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: 18233958
• MDR Text Key: 329315148
• Report Number: 3010667733-2023-00726
• 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: 02/19/2024

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: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/19/2024
• 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 Sex: Male