MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 2+ 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33653208

Device Problem Failure to Osseointegrate (1863)

Patient Problems Rheumatoid Arthritis (1724); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 11/22/2023

Event Type  Injury  

Event Description

It was reported that the patient required a revision surgery due to tibial tray loosening 6 weeks post-op.The patient was diagnosed with rheumatoid arthritis after the initial surgery.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that the patient required a revision surgery due to tibial tray loosening 6 weeks post-op.The patient was diagnosed with rheumatoid arthritis after the initial surgery.

Manufacturer Narrative

The reported event could be confirmed since the device was explanted and returned for evaluation.The device inspection revealed the following: the poly was returned connected to the tibial tray and could not be detached.Scratches and deformation most likely resulting from explantation of the device are visible on the poly.Key dimensional measurements were taken with a digital caliper and found to be within dimensional specifications.Upon further investigation of the received information by healthcare professionals the following was observed: ¿from the additional information given in this case (failure six weeks after the implantation but no confirmed infection) it can be assumed, that the poor bone stock and additional patient related problems (ra) have contributed to the failure.A different implant would have been chosen by the surgeon-at least that is stated- to prevent the implant from early loosening.¿ r&d reviewed microscopic images of the poly and noted the following: "there appears to be embedded debris on the surface of the uhmwpe insert articular surface.The debris appears to range from 1mm to 3mm in maximum dimension.Debris seems to be denser on the anterior and posterior ends of the articular surface.There is no apparent difference in distribution between the medial and lateral condyles (this is by gross observation, not formal statistical analysis).The electron dispersive spectroscopy (eds) indicated that these particulates are a titanium-based alloy.There is no indication of when these particulates were embedded into the articular surface.There appear to be many scratches along the anterior-posterior axis on both condyles.There are also many damage marks that are pit-like, although it does not appear to be "pitting" which is a distinct wear phenomenon.On the posterior side of the insert, there appear to be damage marks from drilling and gouge marks on the posterior end of the inferior side.These marks are both consistent with damage associated with removal of an implant (drilling tool and rongeur, respectively).Unfortunately, it is not possible for us to distinguish wear scars (obtained from articulation and use of the implant) from damage induced during the removal of the insert from the patient.Additionally, our eds is not validated for positive material identification and is used for our reference." based on investigation, the root cause was attributed to a patient related issue.The failure was most likely caused by poor bone stock and the rheumatoid arthritis experienced by the patient.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 more information is provided, the case will be reassessed.

• Brand Name: INFINITY POLY SZ 2+ 8MM TOTAL ANKLE SYSTEM
• 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: 18342205
• MDR Text Key: 330658453
• Report Number: 3010667733-2023-00783
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122674
• UDI-Public: 00840420122674
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140749
• 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: 04/01/2024

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: 33653208
• Device Lot Number: 1663318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/17/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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