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
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem 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.
Additional 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 or Problem 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
• 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): 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
• Report Number: 3000931034-2021-00290
• Device Sequence Number: 17141082
• Product Code: KWS
• UDI-Device Identifier: 03700386944666
• UDI-Public: 03700386944666
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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?: No
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 79 YR
• Patient Sex: Unknown