MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 42MM X 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWB936
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bacterial Infection (1735); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient attended a revision surgery for a reverse ii implant, implanted in 2014.The patient reported with pain, loosening and infection.It's possible that the infection was caused by metalosis due to implant loosening.
Event or Problem Description
It was reported that the patient attended a revision surgery for a reverse ii implant, implanted in 2014.The patient reported with pain, loosening and infection.It's possible that the infection was caused by metalosis due to implant loosening.
Additional Manufacturer Narrative
Correction: d9/h3, h6 (method code 1).The reported event could be confirmed, since the micro culture and pathology results confirm the infection of the patient by pseudomonas aeruginosa.This conclusion was verified by a medical expert upon review of the patient's case documentation medical expertise : "indeed, from the attached documentation all the evidence points in one direction, that of an infected implant, with positive cultures showing the same bacteria from swabs taken during the first re-operation (surgical debridement and deep swabs) on (b)(6), 2021, and the tissue samples taken during the revision surgery on (b)(6), 2021.The infection was caused by pseudomonas aeruginosa, a gram-stan negative bacteria." moreover, the device inspection did not relevated any factors that could have led the reported problem.The root cause could not be determined.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 42MM X 29MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14186448
• Report Number: 3000931034-2022-00205
• Device Sequence Number: 17619396
• Product Code: KWS
• UDI-Device Identifier: 03700386916151
• UDI-Public: 03700386916151
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: DWB936
• Device Catalogue Number: DWB936
• Device Lot Number: 8345AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 85 YR
• Patient Sex: Male