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

Model Number	STANDARD PTC STEM SIZE 7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/21/2016
Type of Reportable Event	Serious Injury
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: dwf520; aequalis ascend flex reversed tray th +0 offset 3.5mm; serial # (b)(4).Cat: dwf421b; aequalis ascend flex reversed insert dia.42 +6 12.5°; 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.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.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.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Revision surgery for suspicion of infection not yet confirmed.The surgeon removed everything except baseplate (afraid to break everything because excellent bite).

• 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: 13606993
• Report Number: 3000931034-2022-00062
• Device Sequence Number: 19315378
• Product Code: KWS
• UDI-Device Identifier: 03700386944666
• UDI-Public: 03700386944666
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/21/2016

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 Expiration Date: 07/31/2018
• Device Model Number: STANDARD PTC STEM SIZE 7
• Device Catalogue Number: DWF607B
• Device Lot Number: 9217AM
• 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: 06/21/2016
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG