MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM TIBIAL MID SIZE 14MM RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	200010901
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Wound Odor (4866)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient therefore an evaluation of the device cannot be performed.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The patient reported experiencing a severe allergic reaction and infection related to the metal components in a stryker product.They also allege chronic foot pain caused by the implants and have requested an ankle amputation, stating they do not believe they are a suitable candidate for an ankle prosthesis.Postoperatively, the patient¿s primary care physician examined the ankle and noted signs consistent with infection.The patient was subsequently prescribed antibiotics.During a follow-up with the surgeon, they were advised to use number two compression socks.The patient is currently seeking additional medical opinions regarding next steps and has mentioned identifying a surgeon who may be able to perform the ankle amputation.
Additional Manufacturer Narrative
Correction to d4(gtin) and g1(reporting contact).The reported event could not be confirmed, since the device was not returned for evaluation, and no other evidence was 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 currently.A review of the labeling did not indicate any abnormalities.No indication of material, manufacturing or design related problems were found during the investigation.However, as patient alleged the allergic reaction with implant, it has been stated in ifu section f ¿ adverse effects that 2.Although rare, metal sensitivity reactions in patients following joint replacement have been reported.Implantation of foreign material in tissues can result in histological reactions involving production of macrophages and fibroblasts.6.Infection can lead to failure of joint replacement.9.Allergic reactions to prosthetic component material can occur.The device is made from a medical grade titanium alloy and ceramics is not used.Microbiologists reviewed the sterilization procedures, environmental monitoring, bioburden data and dhr and noted the subject device was packaged according to established design and process specifications and was sterilized according to procedure.No deviation for a non-conformance could be found.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The patient reported experiencing a severe allergic reaction and infection related to the metal components in a stryker product.They also allege chronic foot pain caused by the implants and have requested an ankle amputation, stating they do not believe they are a suitable candidate for an ankle prosthesis.Postoperatively, the patient¿s primary care physician examined the ankle and noted signs consistent with infection.The patient was subsequently prescribed antibiotics.During a follow-up with the surgeon, they were advised to use number two compression socks.The patient is currently seeking additional medical opinions regarding next steps and has mentioned identifying a surgeon who may be able to perform the ankle amputation.

• Brand Name: INBONE STEM TIBIAL MID SIZE 14MM RIGHT AND 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21396147
• Report Number: 3010667733-2025-00173
• Device Sequence Number: 9327633
• Product Code: HSN
• UDI-Device Identifier: 00840420123855
• UDI-Public: (01)00840420123855(11)210107(17)290105(10)1793823
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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 Catalogue Number: 200010901
• Device Lot Number: 1793823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2021
• 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: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 46 KG