MAUDE Adverse Event Report: TORNIER S.A.S. AEQ ASCEND FLEX STD HUMERAL STEM 7B ANGLE 132 DEGREES5 L.90 PTC; PROSTHESIS SHOULDER JOINT METAL

Model Number STEM 7B ANGLE 132 DEGREES5 L.90 PTC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/24/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that patient with an ascend flex reversed implant had a traumatic incident which results in a periprosthetic fracture of the aequalis ascend flex stem.After seeing the x-ray surgeon thought maybe the stem was implanted too big, so the fracture could easily occur.

Manufacturer Narrative

Correction: please refer to h6 method and health impact codes the reported event could be confirmed, an x-ray was available to confirm the event details, however the x-ray was not good enough for a sound evaluation, due to that hcp review was not requested.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that patient with an ascend flex reversed implant had a traumatic incident which results in a periprosthetic fracture of the aequalis ascend flex stem.After seeing the x-ray surgeon thought maybe the stem was implanted too big, so the fracture could easily occur.

• Brand Name: AEQ ASCEND FLEX STD HUMERAL STEM 7B ANGLE 132 DEGREES5 L.90 PTC
• Type of Device: PROSTHESIS SHOULDER JOINT METAL
• 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: sharon rivas ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12140325
• MDR Text Key: 260678705
• Report Number: 3000931034-2021-00290
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386944666
• UDI-Public: 03700386944666
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: STEM 7B ANGLE 132 DEGREES5 L.90 PTC
• Device Catalogue Number: DWF607B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 79 YR