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

Catalog Number UNK_WWA

Device Problem Osseointegration Problem (3003)

Patient Problems Ossification (1428); Inadequate Osseointegration (2646)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

The digital stryker prophecy team received a ct scan indicating that the base plate and talus are loose as is the distal portion of the stem.The bone scan also suggests that the stem is loose at least at its bottom part.However, the proximal part of the stem may be well fixed.The patient may require a revision surgery of the baseplate due to this.

Event Description

The digital stryker prophecy team received a ct scan indicating that the base plate and talus are loose as is the distal portion of the stem.The bone scan also suggests that the stem is loose at least at its bottom part.However, the proximal part of the stem may be well fixed.The patient may require a revision surgery of the baseplate due to this.

Manufacturer Narrative

The reported event could 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 internal healthcare professionals the following was observed: "the talar component has subsided a little bit yet shows no radiolucency around it.There are however peri-articular ossifications that most likely limit ankle movement a may by a source of pain." based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to the subsidence of the talar component.Also, according to the medical expert assessment there are peri-articular ossifications that most likely limit the ankle movement and hence may be a source of pain.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: UNKNOWN INBONE TALAR DOME
• 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: 18269216
• MDR Text Key: 329748966
• Report Number: 3010667733-2023-00748
• 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: 02/28/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/28/2024
• 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
• Patient Sex: Male