MAUDE Adverse Event Report: TORNIER INC TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3B 132.5DEG 74MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWF603B

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

Patient Problems Neuropathy (1983); Numbness (2415)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned since it remains implanted in the patient; 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.

Event Description

It was reported that the patient has numbness and tingling in his left ulnar digits.No action taken, observing for now.

• Brand Name: TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3B 132.5DEG 74MM
• 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: 15060492
• MDR Text Key: 296212058
• Report Number: 0001649390-2022-00038
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700434019841
• UDI-Public: 03700434019841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2022

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: DWF603B
• Device Catalogue Number: DWF603B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 103 KG