MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4B 132.5DG 78MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWF604B
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	03/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient underwent left primary shoulder replacement on (b)(6) 2020.Patient presented to surgeon in 2023, with a history of a painful left shoulder, and a discharging sinus (left axilla).Swabs grew the bacteria c.Acnes.Plan: remove all prosthesis (1st stage) / insert an antibiotic cement spacer; return in several months, when clinical markers indicate infection resolved, and implant a new prosthetic left shoulder joint(2nd stage).Today, all prosthesis removed, discarded.Multiple specimens taken for pathology.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device was discarded.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned for investigation.Since this event is a particular issue, the opinion of the medical expert was requested with the limited information available and stated as following: "the timeline between the index surgery in 2020 and the presentation with infection in 2023 speaks against early postoperative infection"."although especially c.Acnes can be present for a longer time before symptoms occur, i would like to state that without further information (like sequential x-rays over time), an intraoperative or early postoperative (wound infection) cause is not likely." "most likely the source is hematogenous (blood borne) infection.There is no information that shows special factors that promoted the event.This event is not device related".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.More detailed information about the complaint event must be available in order to determine the exact root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "patient underwent left primary shoulder replacement on (b)(6) 2020.Patient presented to surgeon in 2023, with a history of a painful left shoulder, and a discharging sinus (left axilla).Swabs grew the bacteria c.Acnes.Plan: remove all prosthesis (1st stage) / insert an antibiotic cement spacer; return in several months, when clinical markers indicate infection resolved, and implant a new prosthetic left shoulder joint (2nd stage).Today, all prosthesis removed, discarded.Multiple specimens taken for pathology".

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 4B 132.5DG 78MM
• 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: 19153473
• Report Number: 3000931034-2024-00210
• Device Sequence Number: 20948336
• Product Code: KWS
• UDI-Device Identifier: 03700434019766
• UDI-Public: 03700434019766
• 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: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Expiration Date: 09/19/2024
• Device Catalogue Number: DWF604B
• Device Lot Number: AC6642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2019
• 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: 73 YR
• Patient Sex: Female