MAUDE Adverse Event Report: TORNIER INC UNKNOWN TORNIER SIMPLICITI 46X17 HUMERAL HEAD; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM

Catalog Number UNK_WTB

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Subluxation (4525); Implant Pain (4561)

Event Date 04/25/2023

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.H3 other text : device disposition unknown.

Event Description

It was reported that the patient presented with subluxation, instability and pain.The patient underwent a revision procedure.

• Brand Name: UNKNOWN TORNIER SIMPLICITI 46X17 HUMERAL HEAD
• Type of Device: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM
• 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: 17011382
• MDR Text Key: 316029261
• Report Number: 0001649390-2023-00113
• Device Sequence Number: 1
• Product Code: PKC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2023

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
• Initial Date Manufacturer Received: 05/05/2023
• Initial Date FDA Received: 05/26/2023
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 77 KG