MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 29MM; PROSTHESIS SHOULDER JOINT METAL

Model Number	GLENOSPHERE CENTERED 42 MM X 29MM
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The sphere did not engage with the baseplate when the sphere was impacted onto the baseplate.Both components (the sphere & baseplate) were left in the patient.Surgeon tried several times to engage the sphere with the baseplate.The dwd167 screwdriver was used to assemble the baseplate and glenosphere together.There was a 3-5 minute delay.This event was a primary surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.Based on previous similar cases, the absence of the peripheral groove around the baseplate, the remained soft tissues between the baseplate and the glenoid sphere or inside the baseplate threading hole are the most probably causes for this reported event.Moreover, if the glenoid sphere is left in the patient with the safety screw not tightened, a greater risk of a sphere/baseplate disassembly cannot be excluded in the future.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.
Event or Problem Description
The sphere did not engage with the baseplate when the sphere was impacted onto the baseplate.Both components (the sphere & baseplate) were left in the patient.Surgeon tried several times to engage the sphere with the baseplate.The dwd167 screwdriver was used to assemble the baseplate and glenosphere together.There was a 3-5 minute delay.This event was a primary surgery.

• Brand Name: AEQUALIS REVERSED GLENOSPHERE CENTERED 42 MM X 29MM
• Common Device Name: PROSTHESIS SHOULDER JOINT METAL
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 12010990
• Report Number: 3000931034-2021-00284
• Device Sequence Number: 4452676
• Product Code: KWS
• UDI-Device Identifier: 03700386935916
• UDI-Public: 03700386935916
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: GLENOSPHERE CENTERED 42 MM X 29MM
• Device Catalogue Number: DWD193
• Device Lot Number: AA5335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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: Other
• Patient Sex: Unknown