MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED UNKNOWN PERIPHERAL SCREW; SHOULDER JOINT METAL PROSTHESIS

Catalog Number UNK_WTM

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prosthesis was implanted in the usa in 2016.Patient came for revision.Glenosphere could not be loosened and removed.Multiple attempts to remove the implant resulted in the entire prosthesis coming out.

Manufacturer Narrative

The reported event could be confirmed, since the device was returned for evaluation.The device inspection revealed the following: scratches coming from the extraction tool were observed only on one side of the baseplate.The operative technique shows the 2 different extraction tools ((b)(6) with extractors (b)(6)) that can be used to separate the glenoid sphere from the baseplate, and which are compatible with the aequalis reversed system.Both extraction tools should leave 2 different marks on the surface of the glenoid sphere.As stated previously, it is not the case here (only one mark).This proves that neither recommended tools have been used or have been use properly.Different functional tests showed that the glenoid sphere was functional: the safety screw could be unscrewed and tightened in the baseplate with no issue to report (done with a hexagonal screwdriver) and the sphere disassembled from the baseplate with no issue to report (done with an extractor screw (b)(6)), back in our offices.The inspection made in the returned product could not determine a link with the patient pain.On a side note, the insufficient bone integration observed between the threaded baseplate and the glenoid bone, and the little angulation of the four multidirectional screw, may explain why the glenoid baseplate and screws could be pulled out of the remaining bone.Moreover, it is important to state that in the pre-operative x-rays none of the 4 screws were broken.The breakage of the 2 reported screws most probably happened during the extraction phase.Furthermore, during investigation, it was not possible to determine the reason of the patient pain, as no information was provided by the user, and nothing could be identified by our medical expert from the x-rays provided.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.More detailed information about the complaint event (patient pain) in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.

Event Description

Prosthesis was implanted in the usa in 2016.Patient came for revision.Glenosphere could not be loosened and removed.Multiple attempts to remove the implant resulted in the entire prosthesis coming out.Additional information received from initial reporter: the patient was treated during the first surgery in the us.We do not have any information related to the primary surgery in the us (hospital name, medical records).Patient then came to (b)(6) to another surgeon because he had pain.During the surgery, it was discovered that the glenosphere could not be removed from the base plate.After several attempts, the complete prosthesis finally came out.The patient was then treated with a cement spacer.On (b)(6) a revision with the biologic pro dense was performed.After about 3 months the second surgery with reimplantation should take place.The planned date was (b)(6).The patient then cancelled the surgery at his own request.At the moment a new date is planned for the end of october.If the surgery will take place is currently not sure.

• Brand Name: AEQUALIS REVERSED UNKNOWN PERIPHERAL SCREW
• Type of Device: SHOULDER JOINT METAL PROSTHESIS
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12147298
• MDR Text Key: 260958488
• Report Number: 3000931034-2021-00291
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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