MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680014
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Fall (1848); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial component.It was reported that the patient fell and fractured tibia and dislodged and migrated tibial component.Patient claims it was not due to a fall or noncompliance.After reviewing post-op x-rays and current x-rays, the physician believes patient did in fact fall or was noncompliant.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of the tibial component.It was reported that the patient fell and fractured tibia and dislodged and migrated tibial component.Patient claims it was not due to a fall or noncompliance.After reviewing post-op x-rays and current x-rays, the physician believes patient did in fact fall or was noncompliant.
Additional Manufacturer Narrative
Correction - h6 (device code) the reported event could be confirmed, based on available medical records and health care professionals.The device inspection was not possible as the product was not returned for investigation.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.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 the tibial component shows some radiolucence and some cysts.It is subsidence anteriorly.Loosening and migration could be confirmed.Pe seems attached with components, no sign of breakage or separation.The talar component shows some radiolucence.Loosening is likely possible.There is no clear evidence of migration.Based on investigation, the root cause was attributed to a patient related issue.The patient falling and/or patient non-compliance has been indicated by treating surgeon in this event.The failure is detected by the radiolucence and subsidence of tibial components and radiolucency around talar component.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS
• Common Device Name: 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: 18660595
• Report Number: 3010667733-2024-00045
• Device Sequence Number: 15454419
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 33680014
• Device Lot Number: 1757263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female