MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED HALF WEDGE BP 35DG DIA 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ504
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
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.
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.
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
Please note the correction regarding h6 (results & conclusion codes): the reported event was confirmed, based on the medical expert evaluation of documents provided by user/third party.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.However, formal medical opinion was sought from an experienced independent medical expert as below.¿the migration of the implant is confirmed.The implant was placed too far anteriorly at a native glenoid that already had insufficient bone stock at the anterior side.Based on investigation, the root cause was attributed to a user related issue.The event migration of the glenoid implant construct (glenoid baseplate and glenosphere) due to insufficient anterior bone support of the glenoid base plate in an already bone deficient glenoid anteriorly.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED HALF WEDGE BP 35DG DIA 25MM
• 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: 17660004
• Report Number: 0001649390-2023-00216
• Device Sequence Number: 7068245
• Product Code: PHX
• UDI-Device Identifier: 00846832092154
• UDI-Public: 00846832092154
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• 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): 10/25/2023

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: DWJ504
• 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: 09/28/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/25/2023
• 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