MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF391B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, the patient had primary left shoulder replacement on (b)(6) 2022.The patient complained of pain, had arthroscopic debridement on (b)(6) 2024, the specimens taken showed infected with c.Acnes bacterium.Multiple arthroscopic washouts / debridement procedures, with insertion of antibiotic beads into joint space and long term antibiotic therapy, with last procedure on (b)(6) 2025.Further specimens taken during this procedure showed persistent c.Acnes infection, though scant.During this procedure, the surgeon made the intra-operative decision, to remove all primary implants and insert a antibiotic spacer, & continue antibiotic (iv and oral) therapy, and have a 2nd stage joint replacement procedure in the following months, when all clinical markers indicate the infection is absent.
Additional Manufacturer Narrative
Section b5 executive summary, section d gtin, expiration date section g manufacturing date, section h cause investigation and clinical signs codes added.The reported event could be confirmed.The device was not returned but evidences were provided based on provided information which match the alleged failure.Since images and data were provided, the opinion of a medical expert was sought and stated as following: the event is confirmed by the positive cultures of cutibacterium acnes, which is known for its delayed onset of symptoms as was the case here.The root cause is usually a patient related factor since c.Acnes is common on the skin in the shoulder area and a well-know causer of periprosthetic infections.This case has all the tell-tale elements.Positive cultures, two-stage revision (explantation of the device, implantation antibiotics loaded spacer and reimplantation after the infection was treated).The images show this story.There are no signs of infection on the x-ray that show the implants of the index surgery, but that can be the case with c.Acnes infections.A device inspection was not possible since the affected device was not returned for investigation.From the provided picture taken just after the devices explantation (soiled implants), no additional information could be observed.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.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by a cutibacterium acnes infection.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient had primary left shoulder replacement on (b)(6) 2022.The patient complained of pain, had arthroscopic debridement on (b)(6) 2024, the specimens taken showed infected with c.Acnes bacterium.Multiple arthroscopic washouts / debridement procedures, with insertion of antibiotic beads into joint space and long-term antibiotic therapy, with last procedure on (b)(6) 2025.Further specimens taken during this procedure showed persistent c.Acnes infection, though scant.During this procedure, the surgeon made the intra-operative decision, to remove all primary implants and insert an antibiotic spacer, & continue antibiotic (iv and oral) therapy, and have a 2nd stage joint replacement procedure in the following months, when all clinical markers indicate the infection is absent.Additional information of the 2nd stage revision, where the antibiotic cement spacer (insitu for approx 6 weeks) was removed.Clinical markers indicative that the chronic infection ahs resolved, according to the surgeon.Thorough debridement / lavage attended to; multiple specimens taken.Full set of revision prosthesis (reverse shoulder replacement) implanted.Cement used for the femoral stem.On reduction, shoulder joint stable through full range of motion.

• Brand Name: TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH B 12.5DG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22512413
• Report Number: 3000931034-2025-00381
• Device Sequence Number: 21182862
• Product Code: KWS
• UDI-Device Identifier: 03700434021066
• UDI-Public: (01)03700434021066(11)220523(17)270523(21)8543AX025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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 Catalogue Number: DWF391B
• Device Lot Number: 8543AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG