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

Model Number	REVERSED INSERT; 36MM; +6; A-12.5°
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery on 09-march-2016 for deep infection at 3 weeks post-op.Stem and baseplate retained as part of single stage i&d and revision for infection.
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.Additional devices listed in this report: cat dwf500 aequalis ascend flex reversed tray centered +0 serial # not reported cat dwd190 aequalis reversed ii glenoid sphere 29/36 serial # not reported it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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 was not possible because the lot number was not communicated.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.

• 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, ; FR
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin ; FR
• MDR Report Key: 13607061
• Report Number: 3000931034-2022-00055
• Device Sequence Number: 13945474
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• 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: 2016
• 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): 03/11/2016

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: REVERSED INSERT; 36MM; +6; A-12.5°
• Device Catalogue Number: DWF361B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2016
• Initial Report FDA Received Date: 02/25/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 73 KG