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U.S. Department of Health and Human Services

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

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ARTHROSURFACE TOEMOTION TOE ARTHROPLASTY SYSTEM; PROSTHESIS, TOE (METATARSOPHALANGEAL), JOINT, METAL/POLYMER, SEMI-CONSTRAINED Back to Search Results
Catalog Number 9P15-S180-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 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 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 2 of 4 submissions for this single event.
 
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 (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 2 of 4 submissions for this single event.
 
Manufacturer Narrative
This case is still under investigaton.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.
 
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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 Key18021936
MDR Text Key326739797
Report Number3004154314-2023-00010
Device Sequence Number1
Product Code LZJ
Combination Product (y/n)N
Reporter Country CodePL
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number9P15-S180-W
Device Lot Number75DA9357
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/02/2023
Initial Date FDA Received10/27/2023
Supplement Dates Manufacturer Received12/07/2023
Supplement Dates FDA Received12/13/2023
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 Number1
Patient Age51 YR
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