MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD183
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
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
The customer reported that the glenosphere would not attach onto baseplate.A different glenopshere was used.This was a different sized implant and the surgeon had to use a different humeral component to match.The same base plate was used.
Additional Manufacturer Narrative
Correction h6 method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.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 as well as the affected device must be available to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that the glenosphere would not attach onto baseplate.A different glenopshere was used.This was a different sized implant and the surgeon had to use a different humeral component to match.The same base plate was used.

• Brand Name: AEQUALIS REVERSED II
• 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12544230
• Report Number: 3000931034-2021-00322
• Device Sequence Number: 20080186
• Product Code: KWS
• UDI-Device Identifier: 03700386935855
• UDI-Public: 03700386935855
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 02/24/2026
• Device Model Number: DWD183
• Device Catalogue Number: DWD183
• Device Lot Number: 1522AW017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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
• Patient Sex: Unknown