MAUDE Adverse Event Report: INTEGRA INTEGRA TITAN PRESS FIT 44MM/18 HUMERAL HEAD; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

A customer called arthrosurface customer service on (b)(6) 2015 to report severe pain and restricted range of motion in the right shoulder and asked if he could get some help regarding the on-going issues.As soon as we were notified of the complaint, patient records were requested and obtained for review on 11/05/2015.The patient's medical records included the history of initial and revision surgeries.After reviewing the records, we realized that none of his surgeries involved arthrosurface's implants.The first implant that the patient had was a 7.0mm arthrex tendenosis screw on (b)(6) 2015 which was revised to an "integra" titan press fit 44mm/ 18 humeral head on (b)(6) 2015.The patient reached out to us assuming that he was revised using an arthrosurface hemicap implant, as suggested by his treating surgeon.Later, the patient was advised to contact the manufacturer of his revised implant for further help.The records were returned to the patient and we retained the patient id cards.We did not hear back from the patient and we retained the patient id cards.The complete complaint file will be maintained as part of the arthrosurface quality system.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INTEGRA TITAN PRESS FIT 44MM/18 HUMERAL HEAD
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): INTEGRA
• MDR Report Key: 17529540
• MDR Text Key: 321065587
• Report Number: MW5136466
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1