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	Unspecified Infection (1930); Inflammation (1932)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the explant was due to an infection.The infection was detected during a post-op follow-up and localized in the anterior inferior deltopectoral incision.The microorganism identified was c.Acnes.The patient had no prior infections near the surgery site.The sterile barrier of the device package was not compromised, and no re-sterilization of the device was performed before surgery.No environmental monitoring alerts related to the device¿s storage were recorded.The infection was resolved by prosthesis explantation and insertion of an antibiotic cement spacer.The surgeon noticed mild inflammation and referred the patient to infectious disease for antibiotics.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the explant was due to an infection.The infection was detected during a post-op follow-up and localized in the anterior inferior deltopectoral incision.The microorganism identified was c.Acnes.The patient had no prior infections near the surgery site.The sterile barrier of the device package was not compromised, and no re-sterilization of the device was performed before surgery.No environmental monitoring alerts related to the device¿s storage were recorded.The infection was resolved by prosthesis explantation and insertion of an antibiotic cement spacer.The surgeon noticed mild inflammation and referred the patient to infectious disease for antibiotics.
Additional Manufacturer Narrative
The reported event was not confirmed, the device returned for evaluation was not sufficient to confirm infection and no other medical evidences were provided.The returned device is in good condition overall.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.Microbiologist reviewed the sterilization procedures, environmental monitoring, bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications, and was sterilized according to procedure.No deviation for a non-conformance could be found.A review of the labeling did not indicate any abnormalities.The alleged issue is of infection which can not be confirmed based on device inspection.Hence, more detailed information about the complaint event as well as the medical records must be available in order to determine the root cause of the complaint event.If any further information is provided, the complaint report will be updated.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19757558
• Report Number: 3000931034-2024-00383
• Device Sequence Number: 12980484
• Product Code: KWS
• UDI-Device Identifier: 03700434021592
• UDI-Public: 03700434021592
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: CZ1922300001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: 69 YR
• Patient Sex: Male