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

Model Number	DWD195
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	04/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
Stryker representative contacted complaint handling team and reported the following issue: "patient (b)(6) underwent a revision surgery due to deep infection.Removal of aequalis ascend flex humeral components (stem and insert) and aequalis reversed glenoid sphere." 1st revision surgery.
Additional Manufacturer Narrative
Correction h10 clinical code, results code, conclusion code.The reported event could be confirmed.The device was not returned but evidences were provided based on the reported data in the clinical study.The event description reported that the patient was diabetic (¿diabetes types i or ii¿ condition checked) and that before the revision surgery, a post-operative deep infection with propionibacterium acnes (¿post-operative deep (¿) infection with proprionibacter acnes¿) was identified.Since data and x-rays were provided, the opinion of the medical expert was requested and stated as following: in this case (.) the x-rays do not show signs of a deep infection" because ¿in cases of early (less than 6-12 weeks) postoperative deep infections, the most common clinical signs are wound leakage, wound healing issues, local wound inflammation, fever and abnormalities in the blood work (esr etc.) (¿) ¿in summary we can speak of an early post-operative deep infection of a well placed aequalis reversed tsa (¿) the fact that the infection was caused by skin bacteria (propionibacterium acnes) in a diabetic patient is a known risk factor¿.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by skin bacteria in a diabetic patient (disease).A review of the device history was not possible because the lot numbers were not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise, the file will be reviewed.
Event or Problem Description
Stryker representative contacted complaint handling team and reported the following issue: "patient (b)(6) underwent a revision surgery due to deep infection.Removal of aequalis ascend flex humeral components (stem and insert) and aequalis reversed glenoid sphere." 1st revision surgery.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE ECCENTRIC 42 MM 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: 13523761
• Report Number: 3000931034-2022-00044
• Device Sequence Number: 17261712
• Product Code: KWS
• UDI-Device Identifier: 03700386935930
• UDI-Public: 03700386935930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DWD195
• Device Catalogue Number: DWD195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/05/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG