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

Model Number	STANDARD HUMERAL STEM SIZE 4A PTC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had been experiencing increasing pain and dysfunction.Diagnostic work up included an aspiraiton of the left shoulder joint which was positive.Subject underwent removal of implants and placement of antibiotic spacer.Patient id: (b)(6).
Additional Manufacturer Narrative
On november 10st, 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.Additional devices listed in this report: cat dwf510 aequalis ascend flex reversed tray low offset th0 serial # (b)(4).Cat dwf361c aequalis ascend flex reversed insert ø36 th+6 std angle 7.5° serial # (b)(4).Cat dwd191 aequalis reversed 29mm glenoid sphere 10° tilted 36mm serial # (b)(4).Cat dwd067 aequalis reversed glenoid baseplate ø29mm long post serial # (b)(4).A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.Infection can be related to several reasons: a previous surgery, a sub-acromial dead space, a poor sterile technique, more fragile patients or younger male patients who have a greater risk.After checking the sterile md release sheets of the complaint parts, no issue has been reported.All concerned results were- compliant.No other complaint has been reported since today regarding infections with parts of the same lots implanted and regarding the traceability history of the lots.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: AEQUALIS ASCEND FLEX
• Common Device Name: PROSTHESIS SHOULDER POLYMER / 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: 13607040
• Report Number: 3000931034-2022-00075
• Device Sequence Number: 16636425
• Product Code: KWS
• UDI-Device Identifier: 03700386944567
• UDI-Public: 03700386944567
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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: Lay User/Patient
• Device Expiration Date: 02/26/2021
• Device Model Number: STANDARD HUMERAL STEM SIZE 4A PTC
• Device Catalogue Number: DWF604A
• Device Lot Number: AA2744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 188 KG