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

Catalog Number	200011902
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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, healthcare professionals opined that- ¿tibial (construct): the tibial construct shows clear radioluncence and large cysts around the stem.The cysts partially destroyed the cortex laterally and led to a periprosthetic erosion (fracture like-lesion).Loosening, but no clear migration can be confirmed with this finding.Pe: the pe is not separated from the tibial tray.However, there is nothing visible in the ct, but the report suspects, the loosening may be the cause of the pe debris.Talar (construct): there is some, rather insignificant, radiolucence.Full tar (construct): the failure may at least partly be caused by the device through debris.The cause of the debris, though, is not clear.There are also further investigations ongoing to exclude signs of infection.An infection would be more patient related.If there is significant debris of the pe, this should be confirmed when the implant is observed and with additional histological material from the bone/joint.¿ based on investigation, the root cause was attributed to a patient related issue.The event was caused by the presence of cysts around the tibial construct which resulted in loosening of the tibial construct.Furthermore, the cysts partially destroyed the cortex laterally and led to a periprosthetic erosion (fracture like-lesion).If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INBONE STEM TIBIAL TOP SIZE 16MM RIGHT AND LEFT
• Common Device Name: 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: 19195728
• Report Number: 3010667733-2024-00259
• Device Sequence Number: 7620437
• Product Code: HSN
• UDI-Device Identifier: 00840420123909
• UDI-Public: 00840420123909
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 200011902
• Device Lot Number: 1651086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male