MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL SYSTEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.The device was not returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

Allegedly, the patient underwent a surgical procedure on the shoulder.It was reported that a patient underwent a revision surgery due to dissociation of glenoid components (glenosphere and baseplate) 3 years after initial surgery.The glenosphere and baseplate were removed (hemi-procedure).The stem was retained.

• Brand Name: PERFORM HUMERAL SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: andrew melchiori ; 10801 nesbitt ave s; bloomington, MN 55437
• MDR Report Key: 11373378
• MDR Text Key: 233316836
• Report Number: 3004983210-2021-00016
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BASEPLATE; GLENOSPHERE
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR