MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TALDOME SZ3 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 33680023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 03/03/2023

Event Type  Injury  

Event Description

It was reported that there is a non-healing wound over anterior ankle which probes down to bone.The patient presented from wound care who expressed concern over a worsening wound on his anterior ankle.The patient unfortunately has a non-healing wound over their anterior ankle which probes down to bone.Given the large wound and likely exposed prosthesis, the needs to return to or for i&d and poly exchange.

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Manufacturer Narrative

The reported event was confirmed, based on available medical record and health care professionals opinion.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.The instructions for use instructs user that: ¿deep wound infection (early or late) which may necessitate removal of the prosthesis.On rare occasions, arthrodesis of the involved joint or amputation of the limb may be required.¿ formal medical opinion was sought from an experienced independent medical expert as below: there is no reason to believe that in the short timeframe between the primary implantation and in this complication, any loosening could be seen as the implant has not yet integrated in the bone at all.Therefore, a ct scan is not helpful for the further assessment, here.However, the surgeon explained the clinical situation in which the patient presented an early infection of the implant (within 6 weeks after implantation) with severe wound healing and closure issues.The patient was transferred to the op for revision with i&d and exchange of the poly insert.There were no results of the specimen taken presented so far, therefore we only have a clinical suspicion of an infection.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by infection at early stage of surgery.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that there is a non-healing wound over anterior ankle which probes down to bone.The patient presented from wound care who expressed concern over a worsening wound on his anterior ankle.The patient unfortunately has a non-healing wound over their anterior ankle which probes down to bone.Given the large wound and likely exposed prosthesis, the needs to return to or for i&d and poly exchange.

• Brand Name: INFINITY ADAPTIS TALDOME SZ3 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16765843
• MDR Text Key: 313557719
• Report Number: 3010667733-2023-00203
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797101547
• UDI-Public: 00889797101547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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 Model Number: 33680023
• Device Catalogue Number: 33680023
• Device Lot Number: 1735785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 99 KG