MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS ASCEND FLEX; PROSTHESIS SHOULDER METAL

Model Number	STANDARD PTC HUMERAL STEM - SIZE 3A - 127.5° - 74MM
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent revision surgery due to dislocation at day 1 post-op.Change of the humeral stem 135° (a+c) to 145° (b+b).Patient id: (b)(6).
Additional Manufacturer Narrative
On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.In the instruction for use " warnings and cautions it is specified to "select the reversed insert trial that corresponds to the stem angle (a, b or c)".Furthermore, the surgical technique described that in primary reversed surgery, the surgeon has to select the "b" (132.5°) stem angle associated with "b" (12.5°) insert angle, so that the final angle of the construct is 145°.The surgeon decided to use a+c which corresponds to 135° which is not the recommended construct.The removal of the reversed tray and insert is a consequence of the removal of the stem to change the angulation.Complaint root cause is attributed to a misuse of the medical device.

• Brand Name: AEQUALIS ASCEND FLEX
• Common Device Name: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): 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
• MDR Report Key: 13606719
• Report Number: 3000931034-2022-00073
• Device Sequence Number: 13942327
• Product Code: KWS
• UDI-Device Identifier: 03700386944536
• UDI-Public: 03700386944536
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: STANDARD PTC HUMERAL STEM - SIZE 3A - 127.5° - 74MM
• Device Catalogue Number: DWF603A
• Device Lot Number: AA2132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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: 66 YR
• Patient Sex: Male