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

Model Number	36 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.
Event or Problem Description
"patient put himself up from a chair and during that moment he felt a breakage of the implant.(b)(6) patient is living in (b)(6), after the incident he flew back to (b)(6).The surgeon who gave him the reversed 2 implant 9 years ago had no possibilities to operate him, so patient went to dr (b)(6).He indicates a breakage of the broken screw thread of the connection screw threads of reversed 2 metaphysis.During surgery we observed a breakage exactly at the point of the pe stick from the connection.We have extracted the metaphysis, then we took the pe stick with a clamp and unscrew it from the stem.We could successfully extract the stem from the humerus.We have extracted the reversed 2 stem, we have tried to extract the cement, but unfortunately it was not possible to extract it in total.Therefore the surgeons made the choice to implant a cemented reversed fracture stem in the distal part of the old cement mantle.We also changed the glenosphere because there was a lot of metallosis and scapula notching.We have cleaned the baseplate and place a new glenosphere.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED CEMENTED METAPHYSIS
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• MDR Report Key: 10918102
• Report Number: 3000931034-2020-00154
• Device Sequence Number: 16509492
• Product Code: KWS
• UDI-Device Identifier: 03700386916328
• UDI-Public: 03700386916328
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

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 Model Number: 36 MM
• Device Catalogue Number: DWB960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other