MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 1 / 1+ 6MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33651106
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.H3 other text : device remains implanted in the patient.
Event or Problem Description
The patient is seeking compensation to address the surgery she is going to need to have.Patient had this surgery because she had "dead bone" in her foot.Patient noticed issues with her ankle a couple months post the procedure.She had a wright medical ankle replacement implanted in (b)(6) 2016 and now the bushing is loose.Doctor did x-rays last week and noticed the difference between the post-op x-rays and the x-rays that were taken last week.Patient reports that the doctor states that he has "never seen this happen before".Patient uses a cane to walk and is in a lot of pain and the ankle is swollen and this procedure has affecting every aspect of her life.Patient maintains she adhered to all mobility instructions provided by the physician post- operatively.
Additional Manufacturer Narrative
The reported event (pain) was confirmed since evaluation of op reports provided indicate the patient had complaints of pain leading to the surgery.Review of the op reports reveals the patient presented with left talar exostosis, left lateral ankle ligament rupture, and left peroneal tenosynovitis.There was no indications in the op report that the implants had failed in anyway, further backed up by the fact the surgeon left the devices in-vivo and also felt the patient had good alignment and stability of ankle following the procedure.Based on the information obtained during this investigation, the root cause was attributed to a patient factors related issue.The event was caused by the development of exostosis around/near the implants, necessitating the need for a surgical intervention.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The current instructions for use provided with these devices lists the following as potential late postoperative complications , "periarticular calcification or ossification, with or without impediment to joint mobility".No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The patient is seeking compensation to address the surgery she is going to need to have.Patient had this surgery because she had "dead bone" in her foot.Patient noticed issues with her ankle a couple months post the procedure.She had a wright medical ankle replacement implanted in november 2016 and now the bushing is loose.Doctor did x-rays last week and noticed the difference between the post-op x-rays and the x-rays that were taken last week.Patient reports that the doctor states that he has "never seen this happen before".Patient uses a cane to walk and is in a lot of pain and the ankle is swollen and this procedure has affecting every aspect of her life.Patient maintains she adhered to all mobility instructions provided by the physician post operatively.

• Brand Name: INFINITY POLY SZ 1 / 1+ 6MM TOTAL ANKLE SYSTEM
• 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: 17238900
• Report Number: 3010667733-2023-00359
• Device Sequence Number: 7177042
• Product Code: HSN
• UDI-Device Identifier: 00840420122582
• UDI-Public: 00840420122582
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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 Expiration Date: 12/14/2023
• Device Model Number: 33651106
• Device Catalogue Number: 33651106
• Device Lot Number: 1569407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 54 KG