MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 6.5MMX35MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWJ135

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

Patient Problems Unspecified Infection (1930); Rash (2033)

Event Date 03/05/2024

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 not available.

Event Description

It was reported that the patient underwent a revision surgery due to a joint infection.The infection was detected through a superficial rash near the incision site.The implants were removed and a depuy spacer was implanted.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 6.5MMX35MM NON STERILE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19005761
• MDR Text Key: 338932182
• Report Number: 0001649390-2024-00145
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832089284
• UDI-Public: 00846832089284
• 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
• Report Date: 03/29/2024

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 Catalogue Number: DWJ135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/29/2024
• 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): Required Intervention
• Patient Sex: Male