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

Catalog Number UNK_WWA

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

Patient Problem Loss of Range of Motion (2032)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that the patient will need to undergo a revision surgery due to gutter impingement with the poly.The surgeon is considering debriding the ankle and exchanging the poly spacer.

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.

Event Description

It was reported that the patient will need to undergo a revision surgery due to gutter impingement with the poly.The surgeon is considering debriding the ankle and exchanging the poly spacer.

Manufacturer Narrative

Correction h6 method code the reported event could not be confirmed based on available medical record and medical expert assessment.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.No indications of material, manufacturing or design related problems were found during the investigation.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 only minor radiolucence and no relevant cysts adjacent to the implant.Therefore neither loosening nor migration can be confirmed for both tibia and talar component.There is gutter debridement described as the cause of the revision.No other complications are detected with the ct scan.¿ 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.There is gutter debridement which is described as the cause of the revision and there is nothing else detected in the ct scans.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN INFINITY POLY
• 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: 18936380
• MDR Text Key: 338068866
• Report Number: 3010667733-2024-00162
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

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: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• 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): Other