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

Device Problem Off-Label Use (1494)

Patient Problem Joint Dislocation (2374)

Event Date 02/25/2016

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 289269767
• Report Number: 3000931034-2022-00073
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386944536
• UDI-Public: 03700386944536
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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: 66 YR
• Patient Sex: Male