MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS SHOULDER PRESS-FIT STEM DIA.15 140 DEGREES L.125 MM TA6V; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWB744
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Bacterial Infection (1735); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient fell off bicycle, now complaining of severe pain and inability to use arm.Xrays and ct show loose glenoid component.The aspiration grew out c.Acnes re-operation with component change.Patient is scheduled for revision surgery.
Additional Manufacturer Narrative
Device will not be returned.When additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was not returned.X-rays were provided for the device.Since data was provided, the opinion of a medical expert was sought and stated as follows: « based on my review, there are additional instances which could have caused the loose glenoid component outside of the patient falling off a bicycle.The presence of a low-grade periprosthetic joint infection (pji) with c.Acnes, may have cause some bone resorption prior to the fall.It is however not sure if this was the case since the positive aspiration may have been based on contamination during the aspiration procedure.If, however, this assumed pji has weakened the fixation of the glenoid component, falling of the bicycle may have caused further loosening (acute on chronic) of the glenoid component, making it symptomatic.More consistent confirmation of the pji can be achieved by looking at the tissue culture samples that were most likely taken during the revision surgery.The surgeon has treated the case as having a pji, as shown by the removal of all prosthetic component and replacing them with an antibiotics-loaded spacer on the post-revision x-ray.» more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
Patient fell off bicycle, now complaining of severe pain and inability to use arm.Xrays and ct show loose glenoid component.The aspiration grew out c.Acnes re-operation with component change.Patient is scheduled for revision surgery.

• Brand Name: AEQUALIS SHOULDER PRESS-FIT STEM DIA.15 140 DEGREES L.125 MM TA6V
• 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: 15047290
• Report Number: 3000931034-2022-00259
• Device Sequence Number: 12584456
• Product Code: KWS
• UDI-Device Identifier: 03700386915871
• UDI-Public: 03700386915871
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K980244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 03/30/2023
• Device Model Number: DWB744
• Device Catalogue Number: DWB744
• Device Lot Number: 8033AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Unknown
• Patient Weight: 107 KG