MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 42MM 9TH B 12.5DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWF422B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Implant Pain (4561)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication: deep infection."patient complaining of ongoing pain- ct aspiration was positive for c acnes" patient will schedule revision surgery.(the adverse event was identified as not related to the study device and possibly related to the surgical procedure).
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication: deep infection."patient complaining of ongoing pain- ct aspiration was positive for c acnes" patient will schedule revision surgery.(the adverse event was identified as not related to the study device and possibly related to the surgical procedure).
Additional Manufacturer Narrative
Correction h6 method code.The reported event could be confirmed, since the x-rays confirm the infection of the patient.This conclusion was verified by a medical expert upon review of the patient's case documentation.The opinion of the medical expert state as following: "the x-rays show a peri-prosthetic radiolucency with soft curved borders (well apricated in the axial direction) and with a defensive thin bone line around the humeral component.This finding usually corresponds with a low-grade infection.Since the infection is not aggressive, the thin white line around the humeral prosthesis shows that the bone has time to defend itself against the lytic influence of the infection.Cutibacterium acnes is a commensal skin bacterial species, notoriously know for these kinds of shoulder arthroplasty infections.So, i conclude that this is most likely a low-grade infection with a commensal skin bacterium (c.Acnes), that occurred during the index shoulder surgery with the subject device.Since no surgery is 100% sterile, this residual risk is covered in the ifu and in the rmf of the subject device." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS REV INSERT 42MM 9TH B 12.5DEG
• 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: 13471129
• Report Number: 3000931034-2022-00034
• Device Sequence Number: 4128900
• Product Code: KWS
• UDI-Device Identifier: 03700434019001
• UDI-Public: 03700434019001
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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 Expiration Date: 01/31/2023
• Device Model Number: DWF422B
• Device Catalogue Number: DWF422B
• Device Lot Number: AB7243043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG