MAUDE Adverse Event Report: TORNIER INC TORNIER HRS SPACER 9MM DIA 20MM LENGTH; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number ARS342001

Device Problems Loss of Osseointegration (2408); Noise, Audible (3273)

Patient Problems Inadequate Osseointegration (2646); Implant Pain (4561)

Event Date 11/22/2023

Event Type  Injury  

Event Description

As reported: "patient had a revive (implant) put in on (b)(6) 2023.Patient came back complaining of pain and a clicking.Dr.Scheduled for a revision on (b)(6) 2023 and it was discovered that the assembly screw had come loose and the proximal body was rotating".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Manufacturer Narrative

The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the received device (spacer) when inspected visually looks in good condition and shows no signs of damage.Moreover, the functional inspection was done by assembling the returned devices and it was observed the whole construct is intact & tightened, there were no signs of loosening.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labelling did not indicate any abnormalities.Based on investigation, the probable root cause was attributed to a patient related issue.As there are multiple patient related factors such as bone condition, activity level, and/or compliance to post-surgical instructions that can contribute to component loosening.If any further information is provided, the complaint report will be updated.

Event Description

As reported: "patient had a revive (implant) put in on (b)(6) 2023.Patient came back complaining of pain and a clicking.Dr.Scheduled for a revision on (b)(6) 2023 and it was discovered that the assembly screw had come loose and the proximal body was rotating".

• Brand Name: TORNIER HRS SPACER 9MM DIA 20MM LENGTH
• 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: 18352813
• MDR Text Key: 330810839
• Report Number: 0001649390-2023-00349
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832092581
• UDI-Public: 00846832092581
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2024
• Device Catalogue Number: ARS342001
• Device Lot Number: AZ1918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• 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: 58 YR
• Patient Sex: Male