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

Model Number 25 MM BASEPLATE LG 15MM

Device Problems Material Fragmentation (1261); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/12/2017

Event Type  Injury  

Manufacturer Narrative

On november 10th, 2020 stryker trauma and extremities acquired tornier (b)(4).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.

Event 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)".

• Brand Name: AEQUALIS REVERSED BASEPLATE
• Type of Device: 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: 13607017
• MDR Text Key: 289271446
• Report Number: 3000931034-2022-00078
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386935947
• UDI-Public: 03700386935947
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2015
• Device Model Number: 25 MM BASEPLATE LG 15MM
• Device Catalogue Number: DWD170
• Device Lot Number: 5930AJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 53 KG