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

Catalog Number UNK_WWA

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

Patient Problems Cyst(s) (1800); Insufficient Information (4580)

Event Date 01/06/2023

Event Type  malfunction  

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

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reason due to subsidence of the tibial component but the surgery is not scheduled at this time.The component seem to be stable at this time.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery for reason due to subsidence of the tibial component but the surgery is not scheduled at this time.The component seem to be stable at this time.

Manufacturer Narrative

The reported event could not be confirmed, based on available medical record and 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.Formal medical opinion was sought from an experienced independent medical expert and he opined below: ¿the tibial component has migrated in the tibial stem.There are no signs of breakage or damage to it visible.While the dorsal part seems to be in place, the anterior end of the tibial component is dislocated proximal dorsal leading to an angulation of 25-30° from being horizontal.The pe cannot be assessed directly in the ct-scan.There are no clear signs of damage or dislocation (although this is possible with the migrated tibial component!).The talus shows some cysts and some radiolucency especially around the anterior part.Therefore a loosening of the talar component cannot be excluded completely.The images are pretty distorted not allowing for an undisturbed assessment.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by migration of tibial component into tibial stem.Also, it seems talar component could be loose, but could not confirm with distorted images.¿ if device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY TIBIAL 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: 16301373
• MDR Text Key: 308922919
• Report Number: 3010667733-2023-00055
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 03/07/2023
• 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 Sex: Female