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

Catalog Number UNK_WWA

Device Problem Degraded (1153)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported that the talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.It was noted that the poly insert showed numerous metallic particles embedded in the bearing surface (arrows).The patient underwent a revision procedure.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed. a review of the device history is not possible because the lot number was not communicated. should additional information become available, it will be provided on a supplemental report.

Manufacturer Narrative

Correction - h6 (results code, conclusion code).The reported event could be confirmed since images of ct scans were provided and shows loosening and subsidence of the talar component and breakage of a screw.A medical professional reviewed the received information and noted the following: ¿poor bone quality and incomplete subtalar fusion led to loosening and subsidence of the talar component and unavoidable breakage of a screw.Continuous motion of the loose implant and screw breakage has led to metal particle debris resulting in metallosis, third-body wear of the bearing surfaces and unavoidable early revision.The root cause is most likely a combination of patient-related (poor bone quality, insufficient healing of the subtalar arthrodesis) and user-related (suboptimal implant position close to the screws) factors.¿.Based on investigation, root cause was attributed to a combination of patient-related and user related factors.The failure was caused by poor bone quality, insufficient healing of the subtalar arthrodesis and suboptimal implant position close to the screws.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the talar components are loose.Has caused significant metallosis in surrounding tissues.At least one of the screws through the plate broke too.It was noted that the poly insert showed numerous metallic particles embedded in the bearing surface (arrows).The patient underwent a revision procedure.

• Brand Name: UNKNOWN POLY INSERT
• 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: 16649526
• MDR Text Key: 312401271
• Report Number: 3010667733-2023-00159
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 05/04/2023

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?: Yes
• 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
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 05/04/2023
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female