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

Model Number	CEMENTED STEM 9X100MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2016
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 ;ebo101 cement restrictor ø24 mm serial # (b)(4).Cat ;dwb960 aequalis reversed cemented metaphysis 36mm 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.
Event or Problem Description
Fist infection refer to mdr# 3000931034-2021-00065.On (b)(6) 2015: rsa for rotator cuff tear.On (b)(6) 2016: suspicion of arthritis with suppuration.Data of crp, inflammation test, was 7.On (b)(6) 2016: for the arthritis with suppuration, insert, sphere and baseplate were removed, and surgeon did debridement and filled with a cement including antibiotics without implants replacement (refer to mdr#3000931034-2021-00065).Infection for the second time, with same patient: (b)(6) 2016: the patient was found with the same type of infection the stem was removed and the space was filled with a cement with antibiotics.No implant replacement was done.

• Brand Name: AEQUALIS REVERSED
• 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: 13606998
• Report Number: 3000931034-2022-00066
• Device Sequence Number: 11245448
• Product Code: KWS
• UDI-Device Identifier: 03700386916212
• UDI-Public: 03700386916212
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2016

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: 06/30/2020
• Device Model Number: CEMENTED STEM 9X100MM
• Device Catalogue Number: DWB945
• Device Lot Number: 0653AQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 55 KG