MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED XL60; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWE433

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561)

Event Date 02/01/2022

Event Type  Injury  

Event Description

It was reported that the patient has been complaining of pain and loss of motion.Xrays showed extensive lucency around the glenoid component and loosening was confirmed during the surgery.The stem, humeral head and glenoid component were removed and revised.

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported that the patient has been complaining of pain and loss of motion.Xrays showed extensive lucency around the glenoid component and loosening was confirmed during the surgery.The stem, humeral head and glenoid component were removed and revised.

Manufacturer Narrative

The reported event could be confirmed, since the x-rays provided confirm the loosening of the device.This conclusion was verified by a medical expert upon review of the patient's case documentation.The opinion of the medical expert state as following: "loosening of the glenoid component is visible by the formation of bony cysts, radiolucencies around the glenoid implant¿s location.Also, loosening was confirmed intraoperatively by the surgeon.The reason associated with the formation of cysts and radiolucencies is the polyethylene wear over a period of 9 years (2013-2022).Polyethylene particles trigger an inflammatory response at the bone/implant interface that causes bone resorption and eventually loosening of the implant." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED XL60
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13685323
• MDR Text Key: 287189357
• Report Number: 3000931034-2022-00141
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434022575
• UDI-Public: 03700434022575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2016
• Device Model Number: DWE433
• Device Catalogue Number: DWE433
• Device Lot Number: 0085AK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• 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
• Patient Age: 78 YR
• Patient Sex: Male