MAUDE Adverse Event Report: TORNIER S.A.S. AEQ ASCEND FLEX STD HUMERAL STEM 2B ANGLE 132 DEGREES5 L.70 PTC; PROSTHESIS SHOULDER JOINT METAL

Model Number	HUMERAL STEM 2B ANGLE 132 DEGREES5 L.70 PTC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
On the (b)(6) 2020: this patient underwent a ascend flex reverse surgery on the right shoulder.After surgery, on (b)(6) 2021, she had a medical check up and a bone fracture was confirmed on the affected part.The patient fall was the cause.The revision was initially scheduled for around (b)(6) 2021 for long stem replacement.But the revision surgery was performed on (b)(6).There was no removal or replacement of the implant, and the surgery was completed with osteosynthesis by fixation using a plate and cable from another company.
Additional Manufacturer Narrative
The reported event that could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More information as well as the affected device must be available in order to determine the exact root cause of the failure.If any information is provided, the investigation report will be updated.A review of the labeling did not indicate any abnormalities.H3 other text : device remains implanted.
Event or Problem Description
On the (b)(6) 2020: this patient underwent a ascend flex reverse surgery on the right shoulder.After surgery, on (b)(6) 2021, she had a medical check up and a bone fracture was confirmed on the affected part.The patient fall was the cause.The revision was initialy scheduled for around (b)(6), 2021 for long stem replacement.But the revision surgery was performed on (b)(6).There was no removal or replacement of the implant, and the surgery was completed with osteosynthesis by fixation using a plate and cable from another company.

• Brand Name: AEQ ASCEND FLEX STD HUMERAL STEM 2B ANGLE 132 DEGREES5 L.70 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): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12232384
• Report Number: 3000931034-2021-00294
• Device Sequence Number: 14579786
• Product Code: KWS
• UDI-Device Identifier: 03700386944512
• UDI-Public: 03700386944512
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: HUMERAL STEM 2B ANGLE 132 DEGREES5 L.70 PTC
• Device Catalogue Number: DWF602B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 11/08/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian