MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED L50; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWE422
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "glenoid component loosening.Aseptic glenoid failure.Investigator review of images on 21 dec 2023 visit: note no component migration, but noted humeral osteolysis at zone 6, 7, and 8 >2cm and glenoid osteolysis at zones 3, 5 and 6 >2mm.Revision surgery on (b)(6) 2024".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.The opinion of the medical expert was requested on this case despite the limited information provided, and stated as follows: failure of total shoulder replacement over time is a known complication.In case of a revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient (radiological and clinical) information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where no such information is available, this assessment is limited.No conclusive statement can be provided, because key clinical information (e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician) and in this case medical imaging is missing.Due to these limitations, i am unable to provide statements about the patient, the procedure, and/or the device in relation to cause of the failure.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "glenoid component loosening.Aseptic glenoid failure.Investigator review of images on (b)(6) 2023 visit: note no component migration, but noted humeral osteolysis at zone 6, 7, and 8 >2cm and glenoid osteolysis at zones 3, 5 and 6 >2mm.Revision surgery on (b)(6) 2024".

• Brand Name: TORNIER PERFORM ANATOMIC GLENOID CORTILOC PEGGED L50
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19756687
• Report Number: 3000931034-2024-00382
• Device Sequence Number: 8987890
• Product Code: KWS
• UDI-Device Identifier: 03700434021844
• UDI-Public: 03700434021844
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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 Catalogue Number: DWE422
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 136 KG