MAUDE Adverse Event Report: TORNIER INC CANNULATED TI STANDARD GLENOSPHERE, 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ1017202
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteolysis (2377)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was conducted using the blueprint planning feature.The reason for the revision was that the patient's baseplate became dislodged from the glenoid within two weeks of the initial surgery.The devices removed during the revision were the baseplate and the glenosphere.The initial surgery encountered challenges, including a drop off on the posterior glenoid due to bone loss, which likely contributed to the baseplate not being properly secured.Additionally, one of the peripheral screws had broken during the initial surgery, but it was not deemed to be the cause of the revision.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
A revision surgery was conducted using the blueprint planning feature.The reason for the revision was that the patient's baseplate became dislodged from the glenoid within two weeks of the initial surgery.The devices removed during the revision were the baseplate and the glenosphere.The initial surgery encountered challenges, including a drop off on the posterior glenoid due to bone loss, which likely contributed to the baseplate not being properly secured.Additionally, one of the peripheral screws had broken during the initial surgery, but it was not deemed to be the cause of the revision.

• Brand Name: CANNULATED TI STANDARD GLENOSPHERE, 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: 17660107
• Report Number: 0001649390-2023-00218
• Device Sequence Number: 17723165
• Product Code: PHX
• UDI-Device Identifier: 00846832085729
• UDI-Public: 00846832085729
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K213124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ1017202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown