MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 50MMX19MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF151
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "pt underwent primary reverse shoulder replacement on (b)(6) 2024.During surgery, the surgeon was unable to complete the surgery.Bone grafting of glenoid bone (using patient's humeral head) under glenoid rev 2 baseplate, was the plan.Bone quality, in both humeral head and glenoid, was found to be very poor/osteopenia.During impaction of bone/prosthesis construct onto prepared glenoid surface, the graft collapsed, and the glenoid vault was unsupportive / soft.Surgeon decided to abandon original plan, and convert to a hemi prosthesis, & graft the glenoid defect, as the 1st stage of a now 2-stage procedure.During surgery on (b)(6) 2024, hemi head removed.Grafted glenoid bone was solid, according to surgeon.Multiple specimens taken.Perform reverse glenoid prosthesis implanted, along with ascend flex reverse tray and poly.Prosthetic shoulder joint reduced and was stable through range of motion".
Additional Manufacturer Narrative
Based on the available information the device was discarded and not available for return if additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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 device is returned or any further information is provided the investigation report will be reassessed.
Event or Problem Description
As reported: "pt underwent primary reverse shoulder replacement on (b)(6)2024.During surgery, the surgeon was unable to complete the surgery.Bone grafting of glenoid bone (using patient's humeral head) under glenoid rev 2 baseplate, was the plan.Bone quality, in both humeral head and glenoid, was found to be very poor/osteopenia.During impaction of bone/prosthesis construct onto prepared glenoid surface, the graft collapsed, and the glenoid vault was unsupportive / soft.Surgeon decided to abandon original plan, and convert to a hemi prosthesis, & graft the glenoid defect, as the 1st stage of a now 2-stage procedure.During surgery on (b)(6)2024, hemi head removed.Grafted glenoid bone was solid, according to surgeon.Multiple specimens taken.Perform reverse glenoid prosthesis implanted, along with ascend flex reverse tray and poly.Prosthetic shoulder joint reduced and was stable through range of motion".

• Brand Name: TORNIER FLEX SHOULDER SYSTEM HEAD HI OFFSET 50MMX19MM
• 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: 20153641
• Report Number: 3000931034-2024-00534
• Device Sequence Number: 11830964
• Product Code: KWS
• UDI-Device Identifier: 03700434021707
• UDI-Public: (01)03700434021707(11)231117(17)281117(21)AG4528042
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: Health Professional
• Device Catalogue Number: DWF151
• Device Lot Number: AG4528042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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: 70 YR
• Patient Sex: Female