MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC UNKNOWN TIBIAL TRAY; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number UNK_WWA

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there was a revision surgery for reasons not explained.

Manufacturer Narrative

Correction - d1, h6 (clinical signs code) the complaint could be confirmed, since the information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: the most obvious reason for revision is infection (patient-related factors).No irregularities referring the primary implant, however, only the x-rays made prior to the explantation and or the retrieval good give us that information.The ct-scan shows the status after removal of the primary implant, and the void filled with a hand-made cement spacer (pmma).This is obviously the first stage of a two-stage revision, in nearly all cases performed because of a periprosthetic joint infection (pji).Furthermore, there is also status after subtalar fusion with the use of three long screws of which two reach beyond the bone (too long), and one is in contact with the pmma.That means per definition that this hardware is also in the infected area, making it more difficult to eradicate the infection.The subtalar fusion has not healed completely, most areas show a delayed/non-union.Additional information obtained from the sales rep indicated the patient had a periprosthetic fracture that compromised the talus which would explain the presence of the three long screws and subtalar fusion.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient underwent a total ankle replacement.The patient presented with infection.It was also noted that the patient had a periprosthetic fracture that compromised the talus.The physician removed the total ankle system and implanted three fixos screws.

• Brand Name: UNKNOWN TIBIAL TRAY
• 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: 15724696
• MDR Text Key: 303050703
• Report Number: 3010667733-2022-00374
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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