MAUDE Adverse Event Report: TORNIER INC UNKNOWN TORNIER PERFORM ANATOMIC AUGMENTED GLENOID IMPLANT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTB

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2022

Event Type  Injury  

Manufacturer Narrative

The reported event that one patient required revision surgery due to loosening could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the national registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.  please note, that reports received from the australian registry are not published reports and therefore web link is not available.Device disposition unknown.

Event Description

The manufacturer received a report from the australian orthopaedic association national joint replacement registry (aoanjrr).The report provides information on the usage and outcomes of the tornier perform anatomic augmented glenoid based on the data collected by the aoanjrr.This report includes an analysis of the clinical data that was collected from april 2004 and august 2022.During the review of the report, it was identified that 1 patient experienced loosening which required revision surgery.

• Brand Name: UNKNOWN TORNIER PERFORM ANATOMIC AUGMENTED GLENOID IMPLANT
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15426380
• MDR Text Key: 299932870
• Report Number: 0001649390-2022-00060
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention