MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680013

Device Problem Osseointegration Problem (3003)

Patient Problems Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in 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 of the tibial component due to periprosthetic lucency and pain to distal tibia.The patient was placed with medial mal screws after concern of possible stress riser occurring there.That did not alleviate the symptoms.The physician also reported of using a more liberal amount of bone cement on the implantation of the components than they normally do and they have a suspicion that this has prevented bone ingrowth.The physician plans to drastically cut back on the amount of cement that they use for this case.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial component due to periprosthetic lucency and pain to distal tibia.The patient was placed with medial mal screws after concern of possible stress riser occurring there.That did not alleviate the symptoms.The physician also reported of using a more liberal amount of bone cement on the implantation of the components than they normally do and they have a suspicion that this has prevented bone ingrowth.The physician plans to drastically cut back on the amount of cement that they use for this case.

Manufacturer Narrative

The complaint could be confirmed, since the information for evaluation matches the alleged failure.Upon further investigation of the ct scans by healthcare professionals the following was observed: the event description can be confirmed.The tibial component seems loosened.There is no sign of clear migration, though.The pe cannot be assessed directly in the ct scan, but there is no indirect sign of loosening or migration.The talar component shows a little bit of radiolucence, but there seems to be no loosening present according to the surgeons assessment.The relation to the surgeon comes from his own assessment, where he mentioned to have used too much cement.This may have contributed to the loosening.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a combination of patient factors and user related issue.The failure was caused most likely, the surgeon comes from his own assessment, where he mentioned to have used too much cement.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY ADAPTIS TIB SZ3LNG INFINITY ADAPTIS
• 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: 17891392
• MDR Text Key: 325232844
• Report Number: 3010667733-2023-00596
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680013
• Device Lot Number: 1639445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2019
• 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