MAUDE Adverse Event Report: TORNIER INC TORNIER HRS LOCKING CAP; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number ARS655200

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 11/30/2023

Event Type  Injury  

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.

Event Description

The patient experienced another shoulder dislocation.X-rays showed no significant issues, and the surgeon approved the patient for physical therapy.The patient began physical therapy, wearing a sling in crowded areas but otherwise using the arm as directed by the physician.The surgeon inserted a larger round piece, a stem, and a plastic disc to fill the gap in the shoulder.The surgeon discussed the possibility of transitioning from a reverse shoulder arthroplasty (rsa) to a regular shoulder, or alternatively, for the patient to consider living with limited shoulder function, as full use may not be achievable.

• Brand Name: TORNIER HRS LOCKING CAP
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19005375
• MDR Text Key: 338933944
• Report Number: 0001649390-2024-00144
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093007
• UDI-Public: 00846832093007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ARS655200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 84 KG