MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTED STEM 12MM X 150MM; PROSTHESIS SHOULDER JOINT METAL

Model Number	CEMENTED STEM 12MM X 150MM
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Not returned to manufacturer.
Event or Problem Description
A dissociation between metaphyseal component and stem.Tornier primary shoulder aequalis reversed ii.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and little further evidence/data was provided.Since the x-rays were provided, the opinion of the medical expert was requested and stated as following: the x-ray taken before the disassociation in (b)(6) 2021 shows "insufficient amount of metaphyseal bone stock".But the date of the x-ray is unknown.The x-ray taken just before the revision of (b)(6) 2021 shows that "the dissociation of the subject device is perfectly clear" and an "insufficient amount of metaphyseal bone stock may have contributed to the disassembly of the components".Patient ¿conditions may have also contributed to this event (several previous revisions on this shoulder, "important co-morbidity: poliomyelitis, making patient dependent on the use of crutches").In this case, the metaphyseal component unscrewed from the stem - no breakage is observed.Based on previous similar cases, it has been observed that the humeral components disassembly/unscrewing problem is often due to an insufficient metaphyseal bone stock to stabilize the metaphysis (no bone around the metaphysis, in particularly at the stem/metaphysis link).The remaining bone at the base of the metaphysis was too weak to resist to the load applied, which results in the metaphysis unscrewing from the stem.As a reminder, one of the contraindications for the aequalis reversed humeral implants is insufficient metaphyseal bone stock which makes the stable securing of humeral components impossible.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
A dissociation between metaphyseal component and stem.Tornier primary shoulder aequalis reversed ii.

• Brand Name: AEQUALIS REVERSED CEMENTED STEM 12MM X 150MM
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12014196
• Report Number: 3000931034-2021-00287
• Device Sequence Number: 17194757
• Product Code: KWS
• UDI-Device Identifier: 03700386916267
• UDI-Public: 03700386916267
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/22/2020
• Device Model Number: CEMENTED STEM 12MM X 150MM
• Device Catalogue Number: DWB951
• Device Lot Number: 6324AD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2003
• 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: 83 YR
• Patient Sex: Male