MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY; TOE HEMICAP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Neither the duration of the hemicap implant in the patient nor the reasons behind inadequate pain relief are unknown.The rep contacted revision surgeon to obtain additional information regarding this incident, but the surgeon never responded.The exact cause for reported pain is unknown.The part and lot information of the device in question are unknown.Hence, a review of the device history records (dhr) cannot be conducted.The package insert (pi) of the device states that this type of event can occur and all risks are addressed in the risk documentation.An appropriate root cause was unable to be determined as necessary information to adequately investigate the reported events was not provided.The patient has been revised to a fusion and hemicap device has been explanted.Should arthrosurface receive any additional information which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly.

Event Description

It was reported that a hemicap patient was revised due to pain.

• Brand Name: HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY
• Type of Device: TOE HEMICAP
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin, ma 02038
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton, ma 02072
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma 02038 ; 5085203003
• MDR Report Key: 8927304
• MDR Text Key: 155641859
• Report Number: 3004154314-2019-00008
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/24/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other