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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Bacterial Infection (1735)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• 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: 14119388
• Report Number: 3000931034-2022-00165
• Device Sequence Number: 19912009
• Product Code: KWS
• UDI-Device Identifier: 03700386926969
• UDI-Public: 03700386926969
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2018
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 91 KG