MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680032

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/14/2024

Event Type  Injury  

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of both the tibial and talar components due to aseptic loosening occurring less than a year after implantation.No trauma, no abnormal event, no evidence of infection.Patient has rheumatoid arthritis and history of fracture many years ago.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient underwent a revision surgery of both the tibial and talar components due to aseptic loosening occurring less than a year after implantation.No trauma, no abnormal event, no evidence of infection.Patient has rheumatoid arthritis and history of fracture many years ago.

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.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 by healthcare professionals the following was observed ¿the talus shows an anterior positioning of the implant.There is some radiolucence and loosening can be confirmed.It is not clear however, whether the positioning was already present after the operation or has developed.Aseptic loosening can be confirmed.Without further x-ray no sound assessment can be given, whether an initial poor positioning (user/measurement related) may have contributed to the failure.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was detected due to radiolucency around the talus and also it shows an anterior positioning of the implant.Hence, loosening can be confirmed.However, whether the positioning was already present after the operation or has developed is not clear.Aseptic loosening can also be confirmed from the hcp.Without further x-ray no assessment can be done regrading whether initial poor positioning (user/measurement related) may have contributed to the failure.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: FLAT CUT TALAR DOME SZ 2 INFINITY ADAPTIS
• 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: 19076566
• MDR Text Key: 339777189
• Report Number: 3010667733-2024-00195
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797073066
• UDI-Public: 00889797073066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191393
• 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: 05/31/2024

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: 33680032
• Device Lot Number: 1743210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2022
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 109 KG