MAUDE Adverse Event Report: ARTHROSURFACE, INC. UNKNOWN SHOULDER DEVICE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

The complaint cannot be verified and a root cause for the reported pain cannot be determined with the limited information available for investigation.It is unknown whether the patient had a partial or total shoulder arthroplasty surgery.The device type and information are unknown.Patient was advised to consult their treating surgeon for diagnosis of the pain.The instructions for use (ifu) document lists all possible adverse effects and all risks are addressed in the risk documentation.Several factors such as stress/ physical loads on the implants, vascularity of the implantation site, surgical techniques employed during implantation, patient factors (such as age, current state of the immune system, bone quality, and sensitivity to device materials), and patient post-op compliance to rehabilitation procedures etc., can have impact on the functional effectiveness of the implanted devices.As the patient did not respond to follow-up emails, the complaint will be considered closed at this time.Any further information received will be documented and reviewed for reportability and submitted via supplemental mdrs.

Event Description

The patient received an unknown arthrosurface shoulder implant on (b)(6) 2019 and has had good recovery.Since (b)(6) 2020, the patient started experiencing pain and reached out to arthrosurface to ask if arthritis can recur.

• Brand Name: UNKNOWN SHOULDER DEVICE
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHROSURFACE, INC.; 28 forge parkway; franklin, ma
• Manufacturer (Section G): PRIMO MEDICAL GROUP; 75 mill st; stoughton, ma
• Manufacturer Contact: phani puppala ; 28 forge parkway; franklin, ma ; 5203003
• MDR Report Key: 10420512
• MDR Text Key: 203374260
• Report Number: 3004154314-2020-00005
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/19/2020

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: 07/19/2020
• Initial Date FDA Received: 08/18/2020
• 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 Outcome(s): Other
• Patient Age: 71 YR