MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATER ALIZED GLENOSPHERE +3 DIA 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ023
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/04/2022
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 was revised after patient complaint and notified physician.Radiographs were taken and the physician stated the implant appeared to have disassociated from baseplate.Patient noticed a difference in the way his shoulder felt after 1 year after being implanted.Radiographs are available pre and post operative, no remarkable circumstances noted to contribute to this event.Patient required revision after physician documented via radiographs that the glenosphere appeared to become disassociated from well-fixed baseplate.Other implants noted for the reverse shoulder arthroplasty were glenoid baseplate, x 2 screws, humeral cup, poly and humeral stem.The explanted implants were requested to be returned at the time of the revision surgery but have not received these back from hospital to date.
Additional Manufacturer Narrative
Please note the correction to d9/h3 -product not returned.The reported event could be confirmed the device was not returned for evaluation; however, x-rays were sent for evaluation.No other evidences were provided for investigation.Since data was provided, the opinion of the medical expert was sough and stated as follows: "the x-rays that you¿ve sent indeed confirm the disassembly of the glenosphere and correction of the disassembly after the revision surgery.There are many reasons why this could happen, but without further clinical information and examination of the retrieval this is difficult to say.Most common reason are material interposition at the taper level (blood, debris, gauze), misalignment of the taper during implantation, insufficient impaction during implantation, taper damage during implantation, shoulder instability, disturbed joint mechanics and trauma.For further assessment we would need: early postoperative x-ray of the index procedure, surgical report on both the index and revision surgery and most desirable, retrieval of the explanted glenosphere".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.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.H3 other text: device disposition is unknown.
Event or Problem Description
It was reported that the patient was revised after patient complaint and notified physician.Radiographs were taken and the physician stated the implant appeared to have disassociated from baseplate.Patient noticed a difference in the way his shoulder felt after 1 year after being implanted.Radiographs are available pre and post operative, no remarkable circumstances noted to contribute to this event.Patient required revision after physician documented via radiographs that the glenosphere appeared to become disassociated from well-fixed baseplate.Other implants noted for the reverse shoulder arthroplasty were glenoid baseplate, x 2 screws, humeral cup, poly and humeral stem.The explanted implants were requested to be returned at the time of the revision surgery but have not received these back from hospital to date.

• Brand Name: TORNIER PERFORM REVERSED LATER ALIZED GLENOSPHERE +3 DIA 39MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15712568
• Report Number: 0001649390-2022-00089
• Device Sequence Number: 17429323
• Product Code: PHX
• UDI-Device Identifier: 00846832090389
• UDI-Public: 00846832090389
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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: 01/03/2025
• Device Model Number: DWJ023
• Device Catalogue Number: DWJ023
• Device Lot Number: CZ1419340003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Male