MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC FLATCUT TALAR DOME SZ 1 INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33680031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient as just under 2 weeks out from total ankle replacement with medial mall screw.The patient came in for routine postop visit on (b)(6) 2022.It was noted upon wound inspection that there was some drainage from the medial wound.Upon palpation there was a frank purulence.Because of this, indicated for i&d.An mri showed some possible connection of the fluid medially along with out of the anterior tibia along the side of the implant.The patient has been on iv antibiotic therapy with rocephin and daptomycin.The patient is keeping the fool elevated, has been non-weight bearing in a splint and taking a baby aspirin twice daily for dvt prophylaxis.The pain is well controlled and the infection is improving.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the patient as just under 2 weeks out from total ankle replacement with medial mall screw.The patient came in for routine postop visit on (b)(6) 2022.It was noted upon wound inspection that there was some drainage from the medial wound.Upon palpation there was a frank purulence.Because of this, indicated for i&d.An mri showed some possible connection of the fluid medially along with out of the anterior tibia along the side of the implant.The patient has been on iv antibiotic therapy with rocephin and daptomycin.The patient is keeping the fool elevated, has been non-weight bearing in a splint and taking a baby aspirin twice daily for dvt prophylaxis.The pain is well controlled and the infection is improving.

• Brand Name: FLATCUT TALAR DOME SZ 1 INFINITY ADAPTIS
• 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: 16018781
• Report Number: 3010667733-2022-00463
• Device Sequence Number: 15193620
• Product Code: HSN
• UDI-Device Identifier: 00889797073059
• UDI-Public: 00889797073059
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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 Model Number: 33680031
• Device Catalogue Number: 33680031
• Device Lot Number: 1718309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 5 KG