MAUDE Adverse Event Report: ARTHROSURFACE, INC. HEMICAP HUMERAL HEAD XL (HHXL) ARTICULAR RESURFACING SYSTEM; HEMICAP OVO IMPLANT

Catalog Number 8156-0032-A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Abscess (1690)

Event Type  malfunction  

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.No sterility, packaging or manufacturing related issues were noted per lot dhr review.No other complaints concerning a serious injury or a device malfunction were reported from this device lot.If any further information is found which would change or alter any conclusions or information, a supplemental mdr will be filed accordingly.Arthrosurface will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 3004154314-2019-00002 and 3004154314-2019-00004.

Event Description

On 05/10/19, arthrosurface received a voluntary fda medwatch report filed by a patient.Per the report, the patient received arthrosurface glenoid implant in 2018.Following the initial surgery, patient underwent 3 additional surgeries later in the year due to ongoing complications which involved pus formation and loosening of the glenoid component.The patient was concerned since the arthrosurface device loosened within less than 6 months of implantation.At the time of this report, the patient is scheduled for revision to a reverse shoulder implant of unknown manufacturer.

• Brand Name: HEMICAP HUMERAL HEAD XL (HHXL) ARTICULAR RESURFACING SYSTEM
• Type of Device: HEMICAP OVO IMPLANT
• 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: 8681229
• MDR Text Key: 204761207
• Report Number: 3004154314-2019-00003
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Catalogue Number: 8156-0032-A
• Device Lot Number: 75BH1335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization