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
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3000931034-2022-00141
• Device Sequence Number: 17421090
• Product Code: KWS
• UDI-Device Identifier: 03700434022575
• UDI-Public: 03700434022575
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2022

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 06/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male