MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DG 82MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF605B
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	09/03/2025
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 revision surgery of shoulder was needed after infection of shoulder implant.It will be 2 stage revision.Post this revision the spacer has been left in patient.
Event or Problem Description
It was reported that, the revision surgery of shoulder was needed after infection of shoulder implant.It will be 2 stage revision.Post this revision the spacer has been left in patient.
Additional Manufacturer Narrative
Device was not returned for evaluation, but the reported event could be confirmed with provided evidence.A device inspection was not possible since the affected device was not returned for investigation.From the provided pictures taken in the operating room just after the devices explantation soiled devices, we can observe that the removed humeral stem has soft tissues/bone attached on its surface.No additional information could be observed.Since x-rays and pictures of the extracted implants soiled were provided, the opinion of a medical expert was sought and stated as follows: the implant components are all intact, well aligned and well-fixed to the bone.Evidence of good humeral stem component fixation is shown by the bone that is still attached to the humeral implant.Although we cannot prove the event from the x-rays, the medical information on one of the images shows that the aspirate the fluid that was taken out of the joint preoperatively with a needle contained staphylococcus lugdunensis, which is a bacterium that can cause serious bone and joint infections.Since staphylococcus lugdunensis can also cause endocarditis with a high mortality rate, i understand the aggressive treatment of implant removal of even well-fixed implants.The event is confirmed with proof positive culture of joint fluid showing s.Lugdunensis.The root cause is due to a patient condition which cannot be further specified due to the lack of relevant information.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.The root cause is due to a patient condition which cannot be further specified due to the lack of relevant information.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 5B 132.5DG 82MM
• 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: 23208719
• Report Number: 3000931034-2025-00529
• Device Sequence Number: 9729427
• Product Code: KWS
• UDI-Device Identifier: 03700434021592
• UDI-Public: 03700434021592
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: DWF605B
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 80 YR
• Patient Sex: Female