MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number ARS655200

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent a reverse total shoulder arthroplasty.Allegedly, the locking cap cross threaded within the size 15 proximal body and wouldn't allow the tray to capture the morse taper.Had to take out the failed implant and replace with a new implant.No patient complications were reported despite an hour delay in surgery.

Event Description

It was reported that the patient underwent a reverse total shoulder arthroplasty.Allegedly, the locking cap cross threaded within the size 15 proximal body and wouldn't allow the tray to capture the morse taper.Had to take out the failed implant and replace with a new implant.No patient complications were reported despite an hour delay in surgery.

Manufacturer Narrative

Additional information d9, h3, h6.H6: the proximal body was returned for review.A functional analysis was performed using another locking cap.The locking cap was unable to be threaded into the returned proximal body.Upon further analysis, it appears when the initial locking cap was assembled to the proximal body it cross threaded and ruined the threads in the proximal body.

• Brand Name: AEQUALIS FLEX REVIVE SHOULDER SYSTEM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 10787926
• MDR Text Key: 214649159
• Report Number: 3004983210-2020-00035
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARS655200
• Device Lot Number: AZ0619290157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 12/20/2020
• Patient Sequence Number: 1
• Patient Age: 61 YR