MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS RESURFACING HEAD 48 MM X 18 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWD806

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

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient had a post-operative complication.The patient had to undergo re-operation without component change: arthroscopic debridement, adhesiolysis biopsies for cultures and sub acromial decompression, showing 2 positive bacterial cultures (1 for c acnes and 1 for gram positive rods).Patient has been treated with antibiotics.The adverse event is still ongoing.No additional information is available.

Event Description

It was reported that the patient had a post-operative complication.The patient had to undergo re-operation without component change: arthroscopic debridement, adhesiolysis biopsies for cultures and sub acromial decompression, showing 2 positive bacterial cultures (1 for c acnes and 1 for gram positive rods).Patient has been treated with antibiotics.The adverse event is still ongoing.No additional information is available.

Manufacturer Narrative

The reported event could be confirmed, since the pathology report confirm the infection of the patient.This conclusion was verified by a medical expert upon review of the patient's case documentation.The opinion of the medical expert state as following: "the pathology report confirms the inflammatory response in the glenohumeral joint and fits well with the infection that was diagnosed on the basis of the positive cultures." more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population." 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.

• Brand Name: AEQUALIS RESURFACING HEAD 48 MM X 18 MM
• 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): 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: 14119388
• MDR Text Key: 289346147
• Report Number: 3000931034-2022-00165
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386926969
• UDI-Public: 03700386926969
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/08/2023
• Device Model Number: DWD806
• Device Catalogue Number: DWD806
• Device Lot Number: 2222AT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 91 KG