MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 08/15/2022

Event Type  Injury  

Event Description

It was reported that the patient had positive intraoperative cultures for c.Acnes.The patient completed 6 weeks oral amoxicillin and the issue was resolved without a sequelae.

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.

Manufacturer Narrative

Please note the corrections made to the h6 results code and conclusion code: the reported event was confirmed.The devices were not returned (remained implanted in patient) but evidences were provided based on the reported data in the clinical study.Since data were provided, the opinion of a medical expert was sought and stated as following: "the adverse event of infection is not device related.It is a well-known infection type especially in males with a low-virulent skin bacteria, c.Acnes.It is known that this kind of surgical site infection can be dormant for a longer time before becoming symptomatic (several years after index) surgery, as is the case here.So, the risk factors for an infected shoulder arthroplasty device in this case are male and c.Acnes".In more detail: "the complaints were first documented 5 years after the index-surgery in (b)(6) 2021.The glenoid component gets loose shortly thereafter, documented in (b)(6) 2022.During the revision surgery in (b)(6) 2022 the surgeon takes tissues cultures intraoperatively to rule out infection as a cause of the glenoid loosening.These tissue cultures were positive for c.Acnes, confirming there was a deep infection.Therefore, with the information available, my conclusion is that this was a dormant contamination that became symptomatic 5 years after the index-surgery".Based on investigation, the root cause was attributed to a patient related issue.The adverse event of infection was caused by skin bacteria (c.Acnes disease), leading to pain and the need for revision surgery.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.No indications of material, manufacturing or design related problems were found during the investigation.If the devices are returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient had positive intraoperative cultures for c.Acnes.The patient completed 6 weeks oral amoxicillin and the issue was resolved without a sequelae.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD BASEPLATE 25MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16310556
• MDR Text Key: 308913738
• Report Number: 3000931034-2023-00052
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092116
• UDI-Public: 00846832092116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: DWJ401
• Device Catalogue Number: DWJ401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 91 KG