MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM® REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ742
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient underwent a revision due to glenoid baseplate loosening and a snapped superior screw.During the revision it was confirmed that the baseplate was loose in the patient's glenoid.There was also excessive wear on the humeral poly insert.The humeral stem was well fixed.
Event or Problem Description
It was reported that the patient underwent a revision due to glenoid baseplate loosening and a snapped superior screw.During the revision it was confirmed that the baseplate was loose in the patient's glenoid.There was also excessive wear on the humeral poly insert.The humeral stem was well fixed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and ¿implant ¿ breakage post-operative¿ was confirmed by the hcp.The device inspection revealed the following: the visual inspection of the received device shows that the screw has undergone a brittle fracture on its tip.The thread of the screw is also chipped from middle of its pitch.The other broken section of the screw was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since, the device was returned, photos of the device were sent to seek a formal medical opinion from an experienced medical expert and it is as follows: the images show that this is typically damage neither attributable to implant removal, nor to implantation.Since we have no x-rays on the positioning of the components, the position of the implant within the body cannot be assessed.Nevertheless, the absence of visible bone ingrowth and the broken screw are both arguments in favor of the reported loosening by the surgeon.Lack of bone ingrowth, poor bone quality in this patient with rheumatoid arthritis and mechanical abutment of the pe-liner against the glenoid component may have all contributed to the alleged loosening.Based on investigation, the root cause was attributed to a patient related issue.As per hcp, the failure could have been caused by either lack of bone ingrowth and / or poor bone quality in this patient with rheumatoid arthritis, and / or mechanical abutment of the pe-liner against the glenoid component.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PERFORM® REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13691014
• Report Number: 3004983210-2022-00045
• Device Sequence Number: 1944572
• Product Code: PHX
• UDI-Device Identifier: 00846832091287
• UDI-Public: 00846832091287
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/20/2020
• Device Model Number: DWJ742
• Device Catalogue Number: DWJ742
• Device Lot Number: AZ2015148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown