MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680032

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 12/21/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.

Manufacturer Narrative

The reported event could not 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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.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 a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition unknown.

Manufacturer Narrative

The reported event could not 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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.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 a girdle-stone situation visible in the respective ct scan.There is no further information available in this case, but an infection is likely the cause for the removal of the implant.The initial implantation was in august 2023, therefore the infection is after less than 6 months and therefore there is a little chance, that the infection occurred as a result of the implantation.Without any more information on the case this cannot be assessed with certainty." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.According to the medical assessment performed by the hcp, it was identified that there is a girdle-stone situation visible in the ct scan and hence infection can be the likely cause for the removal of the implant, also there is a little chance that the infection occurred as a result of the implantation, but without any further information on the case this cannot be assessed with certainty.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient underwent a a device explant surgery for reasons that are not available at the time of this report.

• Brand Name: FLAT CUT TALAR DOME SZ 2 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: 18797949
• MDR Text Key: 336446955
• Report Number: 3010667733-2024-00118
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073066
• UDI-Public: 00889797073066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• 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: 05/16/2024

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: 33680032
• Device Lot Number: 1743880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2022
• 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): Required Intervention
• Patient Sex: Female