MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4 39MM DIA +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWP2390

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problem Joint Dislocation (2374)

Event Date 03/20/2024

Event Type  Injury  

Event Description

A patient underwent surgery for shoulder issues, experiencing popping sensations.A significant pop occurred while lifting a 50-pound bag of feed, leading to the discovery of poly dissociation with metal fragments visible on x-ray.Surgery was performed to remove old poly and debris and replace it with new poly.Post-op x-rays showed favorable results.The hospital required the implant to be tested by pathology, with the patient expecting to receive it back in a couple of weeks.Notable circumstances include the patient's active lifestyle as a farmer.Some debris was observed initially but appeared to have been successfully removed during the procedure.

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.

• Brand Name: PERFORM REV INSERT SZ 3/4 39MM DIA +0
• 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: 19120377
• MDR Text Key: 340339536
• Report Number: 0001649390-2024-00162
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832084487
• UDI-Public: 00846832084487
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWP2390
• Device Lot Number: 9145AV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 77 YR