MAUDE Adverse Event Report: ARTHROSURFACE TOEMOTION TOE ARTHROPLASTY SYSTEM; PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED

Catalog Number 9M52-1535-W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Infection (4544); Reaction to Medicinal Component of Device (4574)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On (b)(6) 2023 the distributor reported to arthrosurface that a 51-year-old patient of unknown sex received a toemotion system implant on an unspecific date.The name of the surgeon and clinic name and location who performed the implant procedure was not provided.The doctor reportedly diagnosed the patient with a reaction (reportedly appeared to be osteolysis) but did not specifically allege that the patients local reaction was caused or contributed by the toemotion implant.Additional review of the initial and post op x-ray images provided by engineering at arthrosurface, stated that the reaction may also indicate a local infection or a nickel allergy.Additional information was solicited.The distributor replied to the request for additional information, reporting that the patient was scheduled for a follow up with the surgeon on an unspecified date in october and an allergy test and crp exam will be performed.A mir was submitted to urzad rejestracji produktow lechzen (office for registration of medicinal products, medical devices and biocidal products (poland) under mtpc reference number 2023/528 for this event.There are four components related to this system level complaint, therefor a mdr will be submitted for all four components.This is 3 of 4 submissions for this single event.

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: the reported event is not confirmed.The cause of the reported event cannot be confirmed.Based on the information provided, there were no reported issues or abnormalities with the packaging or device during its use.The distributor stated the diagnosis of osteolysis was hypothetical and not an exact diagnosis that the patient may have an allergy or infection.The patient had an appointment on an unspecified date in october and an allergy test and crp exam was performed.The doctor report that the patient was diagnosed with a surface infection and that there is no temporal association between the patient's skin infection and the implanted device.The patient's crp was reported to be low.The current status of the patient is unknown.A review of the batch record was performed by the manufacturing plant.The device was reported to be manufactured to specification.A supplemental report will be submitted upon receipt of new and relevant information.This case will be monitored and trended for future analysis.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 02 october 2023 the distributor reported to arthrosurface that a 51-year-old patient of unknown sex received a toemotion system implant on an unspecific date.The name of the surgeon and clinic name and location who performed the implant procedure was not provided.The doctor reportedly diagnosed the patient with a reaction (reportedly appeared to be osteolysis) but did not specifically allege that the patients local reaction was caused or contributed by the toemotion implant.Additional review of the initial and post op x-ray images provided by engineering at arthrosurface, stated that the reaction may also indicate a local infection or a nickel allergy.Additional information was solicited.The distributor replied to the request for additional information, reporting that the patient was scheduled for a follow up with the surgeon on an unspecified date in october and an allergy test and crp exam will be performed.A mir was submitted to urzad rejestracji produktow lechzen (office for registration of medicinal products, medical devices and biocidal products (poland) under mtpc reference number (b)(4) for this event.There are four components related to this system level complaint, therefor a mdr will be submitted for all four components.This is 3 of 4 submissions for this single event.

• Brand Name: TOEMOTION TOE ARTHROPLASTY SYSTEM
• Type of Device: PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED
• Manufacturer (Section D): ARTHROSURFACE; 28 forge parkway; franklin MA 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill street; stoughton MA 02072
• Manufacturer Contact: keith kelly ; 28 forge parkway; franklin, MA 02038
• MDR Report Key: 18022569
• MDR Text Key: 326746950
• Report Number: 3004154314-2023-00011
• Device Sequence Number: 1
• Product Code: LZJ
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9M52-1535-W
• Device Lot Number: 75HB9579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR