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U.S. Department of Health and Human Services

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

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ARTHROSURFACE, INC. HEMICAP® MTP RESURFACING HEMI-ARTHROPLASTY; TOE HEMICAP Back to Search Results
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.
 
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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 Key8927304
MDR Text Key155641859
Report Number3004154314-2019-00008
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131377
Number of Events Reported1
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 Received08/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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