MAUDE Adverse Event Report: UNKNOWN TIBIAL BOTTOM STEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

Device Problems Loss of Osseointegration (2408); Migration (4003)

Patient Problems Cyst(s) (1800); Inadequate Osseointegration (2646)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

The reported event could be confirmed, based on available medical records and assessment of health care professionals.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: after reviewing hcp opinion and surgeon¿s feedback we can conclude that tibial components shows radiolucence and smaller cysts and there is some subsidence as well.Pe seems attached with components, no sign of breakage or separation.The talar component shows radiolucency and large cysts, hence component likely loose and migration cannot be confirmed.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the subsidence around tibial components and large cyst around talar component.If device is returned or any further information is provided, the investigation report will be re-assessed.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 of the tibial and talar components due to tibial tray loosening.

• Brand Name: UNKNOWN TIBIAL BOTTOM STEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• MDR Report Key: 18717711
• MDR Text Key: 335523159
• Report Number: 3010667733-2024-00068
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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
• Date Manufacturer Received: 01/22/2024
• 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