MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWJ512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient fell on ice and got a dislocated shoulder.The emergency room was unable to relocate shoulder so the patient stayed overnight and then was taken to the operating room next morning for relocation under anesthesia.The patient remains pseudoparalytic and will be worked up for a revision rsa.

Event Description

It was reported that the patient fell on ice and got a dislocated shoulder.The emergency room was unable to relocate shoulder so the patient stayed overnight and then was taken to the operating room next morning for relocation under anesthesia.The patient remains pseudoparalytic and will be worked up for a revision rsa.

Manufacturer Narrative

The reported event could not be confirmed.The device was not returned.Since the medical reports were provided, the opinion of the medical expert was requested and stated as following: "the previous surgeries and the trauma are enough reason for chronic instability and the need for re-revision of the right shoulder".More detailed information about the complaint event as well as the affected device must be available in order to determine the exact 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.

• Brand Name: TORNIER PERFORM REVERSED LATER ALIZED BASEPLATE 3MM DIA 29MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 14206480
• MDR Text Key: 290058114
• Report Number: 3000931034-2022-00213
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00846832092079
• UDI-Public: 00846832092079
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2023
• Device Model Number: DWJ512
• Device Catalogue Number: DWJ512
• Device Lot Number: 2412AU012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 147 KG