MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX30MM STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ730

Device Problems Off-Label Use (1494); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 04/17/2023

Event Type  Injury  

Event Description

There was a revision of a perform reversed glenoid.The reverse glenoid implant was loose.Fluids and tissues have been harvested during the revision case for a suspected infection.There were no results of the pathology tests.Once the reverse glenoid has been removed, the surgeon has packed the glenoid vault with some femoral head graft and has converted the stem to a hemi prosthesis.Please note the stem was not revised.

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.

Manufacturer Narrative

Please note the corrections made to the h6 results code, the conclusion code, and the health impact code: the reported event was confirmed through the evaluation of a medical expert.Based on the above investigation and provided information, the root cause was attributed to user related issue as well as a patient related issue.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The medical opinion of a medical expert was requested to evaluate the risk of this event: ¿on the x-ray i can confirm the event of loosening of the glenoid base plate.The use of the perform reversed augmented glenoid implant with the djo humeral stem is off label.The large functional neck shaft-angle due to placement of the humeral stem has led to notching and bone loss.The fact that no screws are broken shows that insufficient bone support is the most likely reason for this event of glenoid component loosening.There is no information regarding the possibility of infection.From my assessment, this is a combination of user and patient-related factors leading to this event if the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

There was a revision of a perform reversed glenoid.The reverse glenoid implant was loose.Fluids and tissues have been harvested during the revision case for a suspected infection.There were no results of the pathology tests.Once the reverse glenoid has been removed, the surgeon has packed the glenoid vault with some femoral head graft and has converted the stem to a hemi prosthesis.Please note the stem was not revised.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX30MM STERILE
• Type of Device: 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: 16935400
• MDR Text Key: 315272390
• Report Number: 0001649390-2023-00098
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832091256
• UDI-Public: 00846832091256
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161742
• 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: 08/23/2023

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 Model Number: DWJ730
• Device Catalogue Number: DWJ730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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: 75 YR
• Patient Sex: Male