MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE POLY SZ 3+ 10MM SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 220224310E

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/06/2024

Event Type  Injury  

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 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

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.

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.

• Brand Name: INBONE POLY SZ 3+ 10MM SULCUS
• 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: 19195936
• MDR Text Key: 341236129
• Report Number: 3010667733-2024-00260
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420125125
• UDI-Public: 00840420125125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100886
• 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: 220224310E
• Device Lot Number: 1649539
• 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