MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM TIBIAL MID SIZE 16MM RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 200010902

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/06/2024

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to tibial component loosening and polyethylene debris.The left ankle was aspirated today through a anteromedial approach and fluid was sent for total cell count, gram stain, culture and sensitivity.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.

• Brand Name: INBONE STEM TIBIAL MID SIZE 16MM RIGHT AND LEFT
• 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: 19195532
• MDR Text Key: 341186232
• Report Number: 3010667733-2024-00257
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420123862
• UDI-Public: 00840420123862
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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: 200010902
• Device Lot Number: 1650858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• 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 Age: 63 YR
• Patient Sex: Male