MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ012

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  Injury  

Event Description

It was reported that the doctor was revising the glenoid components and while taking off the glenosphere the end of the extractor got bent and damaged.Another one was opened and used to complete the case.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Event Description

It was reported that the doctor was revising the glenoid components and while taking off the glenosphere the end of the extractor got bent and damaged.The revision occurred due to dislocation and non union.Another one was opened and used to complete the case.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition is unknown.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 36MM
• 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: 15601179
• MDR Text Key: 301725227
• Report Number: 0001649390-2022-00086
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832090334
• UDI-Public: 00846832090334
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/20/2023

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: Health Professional
• Device Model Number: DWJ012
• Device Catalogue Number: DWJ012
• Device Lot Number: CZ1022091018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention