MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED XL60; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	GLENOID CORTILOC PEGGED
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/03/2022
Type of Reportable Event	Serious Injury
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 patient (b)(6) underwent a revision surgery 10 years after primary study surgery due to glenoid component loosening.(patient noticed worsening pain since (b)(6) 2021 and ct scan shows severe lucency and bone loss surrounding the glenoid component and a non displaced acromion fracture).The glenoid component was removed and bone grafted.
Event or Problem Description
It was reported that patient (b)(6) underwent a revision surgery 10 years after primary study surgery due to glenoid component loosening.(patient noticed worsening pain since (b)(6) 2021 and ct scan shows severe lucency and bone loss surrounding the glenoid component and a non displaced acromion fracture).The glenoid component was removed and bone grafted.
Additional Manufacturer Narrative
Despite the device was not returned, 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: "there are no specific factors that attribute to the reported event.The polyethylene glenoid component has served its estimated lifetime of 10 years.In this case, progressive degeneration of the rotator cuff may have played a role, although this cannot be assessed with certainty from the information at hand.So, there are no specific causes that can be determined from the information available, and that the device has served its expected lifetime." 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 more information is provided, the case will be reassessed.

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED XL60
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• 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: 13392046
• Report Number: 3000931034-2022-00014
• Device Sequence Number: 14647363
• Product Code: KWS
• UDI-Device Identifier: 03700434022575
• UDI-Public: 03700434022575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2016
• Device Model Number: GLENOID CORTILOC PEGGED
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 84 KG