MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED CEMENTED STEM 9MM X 100MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWB945
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the metaphyseal component of rev 2 humurous separated from the stem component in the patients right shoulder.A revision surgery was performed.The surgeon removed the separated metaphyseal component and the stem.They were replaced with new components.
Additional Manufacturer Narrative
The reported event could be confirmed since the x-ray provided matches the alleged failure.Indeed, the provided x-ray taken prior the revision surgery showed a dissociation between the metaphysis and the stem.The metaphysis component was completely disassembled/unscrewed from the stem.A fracture of the proximal humeral bone was also observed on the provided x-ray.On the other hand, the device inspection revealed the following: visually, the first thread of the stem was damaged.On the metaphysis at the level of the metaphyseal portion and at the neck, some cement and bone residues were observed.The plastic anti-rotation plug component located on the threading of the metaphysis was not damaged.Functionally, the metaphysis could screw on the stem without issue to report.The first damaged thread of the stem did not prevent the screwing.Force was needed to continue to screw the metaphysis on the stem at the plastic anti-rotation plug level.The returned devices were fully functional.Since the functional inspection worked, a dimensional inspection was not considered necessary.Since the visual inspection and the functional inspection show no defect, the adverse event is not related to the device.The opinion of the medical expert was requested and stated the following: "it has unscrewed from the distal part, in this case it has to do with the loss of fixation of the metaphysis in its surrounding bone, that¿s the only way the component can get unscrewed.I cannot compare it to the early postoperative x-ray, but it looks like bone resorption and the fracture of the proximal humeral bone has led to this event." in this case, the patient conditions may have also contributed to this event.Unfortunately, as no immediate post-operative x-ray related to the primary surgery was provided, there was no possibility to check the metaphysis/stem assembly/screwing.More detailed information about the complaint event must be available in order to determine the exact root cause of the complaint event.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 is too weak to resist to the load applied, which results in the metaphysis unscrewing from the stem.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the metaphyseal component of rev 2 humurous separated from the stem component in the patients right shoulder.A revision surgery was performed.The surgeon removed the separated metaphyseal component and the stem.They were replaced with new components.

• Brand Name: AEQUALIS REVERSED CEMENTED STEM 9MM X 100MM
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15331969
• Report Number: 3000931034-2022-00284
• Device Sequence Number: 17897764
• Product Code: KWS
• UDI-Device Identifier: 03700386916212
• UDI-Public: 03700386916212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 04/07/2020
• Device Model Number: DWB945
• Device Catalogue Number: DWB945
• Device Lot Number: 8367AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2015
• 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; Hospitalization
• Patient Sex: Female