MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOID BASEPLATE DIA.29MM LONG POST; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number DWD067

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

Patient Problems Bacterial Infection (1735); Implant Pain (4561)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device remains implanted in patient.

Event Description

It was reported that patient had a post-operative complication: deep infection."patient complaining of ongoing pain- ct aspiration was positive for c acnes" patient will schedule revision surgery.(the adverse event was identified as not related to the study device and possibly related to the surgical procedure).

Event Description

It was reported that patient had a post-operative complication: deep infection."patient complaining of ongoing pain- ct aspiration was positive for c acnes" patient will schedule revision surgery.(the adverse event was identified as not related to the study device and possibly related to the surgical procedure).

Manufacturer Narrative

Please note correction of h6 method code.The reported event could be confirmed, since the x-rays 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 x-rays show a peri-prosthetic radiolucency with soft curved borders (well apricated in the axial direction) and with a defensive thin bone line around the humeral component.This finding usually corresponds with a low-grade infection.Since the infection is not aggressive, the thin white line around the humeral prosthesis shows that the bone has time to defend itself against the lytic influence of the infection.Cutibacterium acnes is a commensal skin bacterial species, notoriously know for these kinds of shoulder arthroplasty infections.So, i conclude that this is most likely a low-grade infection with a commensal skin bacterium (c.Acnes), that occurred during the index shoulder surgery with the subject device.Since no surgery is 100% sterile, this residual risk is covered in the ifu and in the rmf of the subject device." 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, â¿¿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 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 device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED GLENOID BASEPLATE DIA.29MM LONG POST
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 13475995
• MDR Text Key: 285328172
• Report Number: 3000931034-2022-00035
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03700386928239
• UDI-Public: 03700386928239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112144
• 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: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWD067
• Device Catalogue Number: DWD067
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG