MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PTC DISTAL STEM DIA 9; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number ARS741801

Device Problem Osseointegration Problem (3003)

Patient Problems Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 07/24/2023

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 is unknown.

Event Description

The tornier shoulder outcomes study's patient experienced a revision surgery due to issues with loosening/lysis.During the procedure, a glenoid sphere was removed and replaced with a reversed-lateralized glenosphere that was 3mm larger (39mm).An additional update revealed that the tornier hrs ars741701 was also removed during the surgery.

Event Description

The tornier shoulder outcomes study's patient experienced a revision surgery due to issues with loosening/lysis.During the procedure, a glenoid sphere was removed and replaced with a reversed-lateralized glenosphere that was 3mm larger (39mm).An additional update revealed that the tornier hrs ars741701 was also removed during the surgery.

Manufacturer Narrative

Please note the correction made to the d4 catalog #, d1 product long description, d2 product code, d2 common device name, d4 lot number, g4 pma/510(k) or bla #: the reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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, design & manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TORNIER HRS PTC DISTAL STEM DIA 9
• 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: 17606936
• MDR Text Key: 321777695
• Report Number: 0001649390-2023-00207
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093014
• UDI-Public: 00846832093014
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 09/26/2023
• Device Catalogue Number: ARS741801
• Device Lot Number: AZ1318019R2034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 99 KG