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

Catalog Number UNK_WWA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Pain (1994); Loss of Range of Motion (2032); Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 06/13/2023

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery.Patient continues to have a lot of pain of the ankle with minimal motion and a lot of pain with any motion of the ankle joint.The ct scan also showed some lucency surrounding the talar component.

Manufacturer Narrative

Device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted.

Manufacturer Narrative

Please note the corrections made to the h6 results code, conclusion code, clinical code: the reported event was confirmed since evaluation of provided ct imaging does find radiolucence anterior to the tibial tray.Upon further investigation of the ct scans by healthcare professionals the following was observed, ¿the tibial component shows some radiolucence anterior and some condensed bone substance indicating stress which could result from loosening." and "when looking through the information received, the event is patient related." based on the investigation, the root cause can be attributed to patient factors related issue.The loosening was caused by radiolucence anterior to the tibial component with condensed bone substance indicating stress.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

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery.Patient continues to have a lot of pain of the ankle with minimal motion and a lot of pain with any motion of the ankle joint.The ct scan also showed some lucency surrounding the talar component.

• Brand Name: UNKNOWN TIBIAL COMPONENT
• 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: 17282898
• MDR Text Key: 318640649
• Report Number: 3010667733-2023-00374
• 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: 10/30/2023

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: 06/13/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/30/2023
• 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): Other
• Patient Sex: Male