MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE; SHOULDER JOINT METAL PROSTHESIS

Model Number	25MM 10° TILTED 36MM
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
"it was reported, during 5yfu, that a patient had a glenoid loosening (xrays show a broken screw and apparent upward migration of glenosphere).Patient id : (b)(6).
Additional Manufacturer Narrative
On november 10th, stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Glenoid loosening problem with a screw rupture at 6 years post-operative.Glenoid loosening can be related to several reasons: initial poor bone quality (osteoporosis) or insufficient quantity of bone stock.Glenoid fracture during the insertion of the baseplate (tapping step not realized for threaded post-baseplate for example).Inadequate choose of the glenoid implant components.Improper positioning of the glenoid implants components.Severe notching phenomenon leading to bone destruction.High wear rate of the polyethylene insert leading to bone resorption.Traumatic event.Reeducation procedure not respected or inadequate patient use in post-op (surgeon advices not respected).Atraumatic osteonecrosis detected into this particular case could have been considered as a contra-indication for a reverse arthroplasty (see instruction for use ifu utawi2017.1).However, not enough information is given into this complaint to determine if the glenoid side was affected or not.Based on the low data available, the root cause could not be clearly determined.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 13607025
• Report Number: 3000931034-2022-00079
• Device Sequence Number: 1957319
• Product Code: KWS
• UDI-Device Identifier: 03700386935831
• UDI-Public: 03700386935831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2017

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: 04/09/2015
• Device Model Number: 25MM 10° TILTED 36MM
• Device Catalogue Number: DWD181
• Device Lot Number: 7965AI
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2010
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 53 KG