MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33680001

Device Problems Device Dislodged or Dislocated (2923); Osseointegration Problem (3003)

Patient Problems Joint Dislocation (2374); Inadequate Osseointegration (2646); Limb Fracture (4518)

Event Date 01/25/2024

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 removal surgery of the current talar implant due to early collapse of the tibial side without trauma.There is a fracture present in the tibia.The physician reported that the patient will need intramedullary fixation.

Event Description

The digital stryker prophecy team received a ct scan indicating that the patient may require a removal surgery of the current talar implant due to early collapse of the tibial side without trauma.There is a fracture present in the tibia.The physician reported that the patient will need intramedullary fixation.

Manufacturer Narrative

The reported event could be confirmed, confirmed based on available ct scans 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: "subsidence and loosening of the tibial tray due to poor bone quality and a fracture of the tibial plafond, thus patient related.No early postoperative x-ray for comparison.Components as such intact".Based on the investigation, root cause was attributed to patient related issue.The failure was caused due to the poor bone quality along with fracture of tibial plafond observed in the ct scans.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY ADAPTIS TIB SZ1 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: 18763889
• MDR Text Key: 336050169
• Report Number: 3010667733-2024-00093
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797069632
• UDI-Public: 00889797069632
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181557
• 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: 05/03/2024

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: 33680001
• Device Lot Number: 1717037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2021
• 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: Female