MAUDE Adverse Event Report: TORNIER INC UNKNOWN BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTB

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2023

Event Type  Injury  

Event Description

Dr.(b)(6) expressed dissatisfaction with the initial positioning of the baseplate, which had been set too high.The baseplate, along with the screws and glenosphere, was subsequently removed.The procedure was not accompanied by any exceptional circumstances.

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.

Manufacturer Narrative

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 images in the blueprint revision plan shows that the primary glenoid baseplate placement is done too high by the user.The planned simulated position of the glenoid revision implant looks good.Based on investigation, the root cause was attributed to a user related issue.The event(clinical necessity for revision) was caused by user who placed the glenoid baseplate too high during the primary surgery.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

Dr.(b)(6) expressed dissatisfaction with the initial positioning of the baseplate, which had been set too high.The baseplate, along with the screws and glenosphere, was subsequently removed.The procedure was not accompanied by any exceptional circumstances.

• Brand Name: UNKNOWN BASEPLATE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 17487652
• MDR Text Key: 320671775
• Report Number: 0001649390-2023-00181
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention