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

Catalog Number 33680014

Device Problems Off-Label Use (1494); Device Handling Problem (3265)

Patient Problems Limb Fracture (4518); Implant Pain (4561); Insufficient Information (4580)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.

Event Description

This event is reportable due to the product mix in the central sterile processing which resulted in the wrong guides being used in the patient.

Manufacturer Narrative

The reported event was confirmed since images of ct scans shows loosening of the tibial component and a non-union of a medial malleolar fracture.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the ct scan shows a non-union of a medial malleolar fracture.The tibial component has migrated, ¿flipping¿ over backwards due to significant anterior subsidence/bone loss.The implant is definitively loose.There is bone adherence to the adaptis layer, yet this bone is loose from the tibial bone.No signs of loosening of the talar component.I conclude the primary root cause is a user-related issue, and possible secondary factors such as bone quality, are patient related.It is difficult to assess the influence of secondary factors in this case.¿ based on investigation, the root cause was attributed to a user related issue.Due to a mix-up in central sterilization, the wrong prophecy guides were used during the primary surgical procedure which resulted in a medial malleolar fracture with insertion of the tibial component.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

This event is reportable due to the product mix in the central sterile processing which resulted in the wrong guides being used in the patient.Two cases involving prophecy guides became mixed up in central sterilization.The first case appeared during surgery, and it was only when the tibial corner holes were drilled that the mistake became evident.The error was traced back to the mixing up of prophecy guides.The surgeon switched to standard instrumentation but inadvertently caused a medial malleolar fracture during the insertion of the tibial component, only detected six weeks later through x-rays.Despite the fracture, the patient chose non-surgical treatment due to work commitments, and the patient experienced relief from pain.Multiple discussions were held about potential revision, but the issue was attributed to technical errors rather than the implants themselves.An update on a later dat, clarified that the primary surgery for this patient is (b)(4), with pi# (b)(6) addressing the revision surgery/primary implants only, and pi# (b)(6) addressing the allegations of mixed up guides and the medial malleolar fracture.Feedback from the sales representative indicated that the mix-up was a result of a processing error in the sterilization department due to staffing shortages and the use of temporary staff.Additional information provided on a later date, confirmed that the guides from one patient were indeed used in another patient's surgery on the same day.The entire set of guides was placed incorrectly, staged for surgery.However, the guides from different cases were not mixed together.The mix-up occurred because the patient information labels on the guides were swapped.The process involved the sales representative delivering and filling out an intake form for the equipment brought in, with sterile processing handling the items and placing them on case carts for each surgery.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG 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: 17561548
• MDR Text Key: 321331562
• Report Number: 3010667733-2023-00444
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: 00889797069694
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131283
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680014
• Device Lot Number: 1719296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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: Male