MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6A 127.5DEG 86MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF606A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that the patient had positive intraoperative cultures for c.Acnes.The patient completed 6 weeks oral amoxicillin and the issue was resolved without a sequelae.
Event or Problem Description
It was reported that the patient had positive intraoperative cultures for c.Acnes.The patient completed 6 weeks oral amoxicillin and the issue was resolved without a sequelae.
Additional Manufacturer Narrative
Please note the correction regarding the h6 results and conclusion code: the reported event was confirmed.The devices were not returned (remained implanted in patient) but evidences were provided based on the reported data in the clinical study.Since data were provided, the opinion of a medical expert was sought and stated as following: "the adverse event of infection is not device related.It is a well-known infection type especially in males with a low-virulent skin bacteria, c.Acnes.It is known that this kind of surgical site infection can be dormant for a longer time before becoming symptomatic (several years after index) surgery, as is the case here.So, the risk factors for an infected shoulder arthroplasty device in this case are male and c.Acnes".In more detail: "the complaints were first documented 5 years after the index-surgery in may 2021.The glenoid component gets loose shortly thereafter, documented in may 2022.During the revision surgery in august 2022 the surgeon takes tissues cultures intraoperatively to rule out infection as a cause of the glenoid loosening.These tissue cultures were positive for c.Acnes, confirming there was a deep infection.Therefore, with the information available, my conclusion is that this was a dormant contamination that became symptomatic 5 years after the index-surgery".Based on investigation, the root cause was attributed to a patient related issue.The adverse event of infection was caused by skin bacteria (c.Acnes disease), leading to pain and the need for revision surgery.A review of the device history was not possible because the lot number was not communicated.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 the devices are returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 6A 127.5DEG 86MM
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16309412
• Report Number: 3000931034-2023-00050
• Device Sequence Number: 20595144
• Product Code: KWS
• UDI-Device Identifier: 03700434020380
• UDI-Public: 03700434020380
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: DWF606A
• Device Catalogue Number: DWF606A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG