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

Catalog Number UNK_WWA

Device Problems Malposition of Device (2616); Osseointegration Problem (3003); Migration (4003)

Patient Problems Cyst(s) (1800); Implant Pain (4561)

Event Date 08/25/2023

Event Type  Injury  

Event Description

It was reported that the patient may undergo a revision surgery due to "pain and impingement, mal-alignment.Implanted in 2016 at another uk site (sheffield).Previous gutter debridement by primary surgeon.".

Manufacturer Narrative

The implant is not available as it is still in the patient.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.H3 other text : device remains implanted in patient.

Manufacturer Narrative

Correction h6 device code, result code, conclusion code.The reported event could be confirmed based on available medical records and assessment from healthcare professional the device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿ there is significant radiolucence around the stem and at the base of the tibial implant.This can be interpreted as a loosening.Migration is not visible in the ct scan.The pe cannot be assessed directly, however, there is no indirect sign of loosening or breakage of the pe.The talar component does show some radiolucence and a little bit of condensed zone around the implant.That indicates loosening and possibly a little bit of subsidence.¿ based on investigation, the root cause was attributed to a patient related issue.Patient¿s poor bone quality around the tibia and condensed bone around the talus alters the physiology resulting in change in implant¿s orientation and contributed to failure.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient may undergo a revision surgery due to "pain and impingement, mal-alignment.Implanted in 2016 at another uk site (sheffield).Previous gutter debridement by primary surgeon.".

• Brand Name: UNKNOWN INFINITY IMPLANT
• 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: 17818905
• MDR Text Key: 324280679
• Report Number: 3010667733-2023-00549
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/15/2023

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 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: 08/25/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/15/2023
• 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