MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 39MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWJ013

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Joint Laxity (4526)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition unknown.

Event Description

It was reported that the patient experienced shoulder instability and a small cyst on the shoulder in (b)(6) 2022.The patient presented for ultrasound/biopsy on (b)(6) 2022.On (b)(6) 2022 post op infection was confirmed.The patient underwent a revision procedure to explant the system and replace it with a spacer.

Manufacturer Narrative

Correction - h6 (device code, clinical signs code, health impact code) the reported event could be confirmed.The device was not returned but evidences were provided based on the reported data in the clinical study.From data provided, it is reported that the patient, a male, "had 6/6 positive intraoperative cultures for c acnes.He has been treated (.) with infectious disease and is currently on iv ceftriaxone".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-know 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.The slow build up of fluid in the joint stretches the soft tissues progressively and may lead to joint instability and the formation of a cysts, that may eventually become a fistula if the infection is left untreated.Other than mentioned above there were no other risk factors for infection".Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by skin bacteria (c.Acnes disease).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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that the patient experienced shoulder instability and a small cyst on the shoulder in (b)(6) 2022.The patient presented for ultrasound/biopsy on (b)(6) 2022.On (b)(6) 2022 post op infection was confirmed.The patient underwent a revision procedure to explant the system and replace it with a spacer.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 39MM
• Type of Device: 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: 16210135
• MDR Text Key: 307743899
• Report Number: 3000931034-2023-00020
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00846832090341
• UDI-Public: 00846832090341
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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: DWJ013
• Device Catalogue Number: DWJ013
• Device Lot Number: CZ4421096021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG