MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, MID SIZE, 16 MM, RIGHT & LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	200010902
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 underwent a total ankle replacement.The patient presented with infection based on wound anterior of tibia at the incision site.The implant was removed and antibiotic cement spacer was inserted antibiotic course prescribed by the surgeon.It was noted that there was remarkable patient circumstances/non-compliance.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available information and medical expert opinion.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.Formal medical opinion was sought from an experienced independent medical expert, and he opined that- ¿with the limited information given and without a view on the clinical situation the assessment must be limited, here.The ct shows the girdlestone-situation with the bone cement as a place holder.The ct can be reconciled with the information given in the report, specifically in the update from (b)(6).As per communication received on 9th january, an infection was found at the anterior aspect of the tibia at the incision, the implant was removed, and a cement spacer was inserted as well as an antibiotic course which was prescribed by the surgeon.¿ 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 underwent a total ankle replacement.The patient presented with infection based on wound anterior of tibia at the incision site.The implant was removed and antibiotic cement spacer was inserted antibiotic course prescribed by the surgeon.It was noted that there was remarkable patient circumstances/non-compliance.

• Brand Name: INBONE STEM, TIBIAL, MID SIZE, 16 MM, RIGHT & LEFT
• 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: 16225035
• Report Number: 3010667733-2023-00029
• Device Sequence Number: 5351903
• Product Code: HSN
• UDI-Device Identifier: 00840420123862
• UDI-Public: 00840420123862
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 200010902
• Device Catalogue Number: 200010902
• Device Lot Number: 1707750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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 Sex: Male