MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2 39MM DIA +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DWP1390

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was discovered that the artificial shoulder joint insert that was implanted on 2/19 had dislocated from the stem one week after surgery.The scheduled revision date is currently under review.

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 1/2 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18942707
• MDR Text Key: 338148145
• Report Number: 0001649390-2024-00117
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832084425
• UDI-Public: 00846832084425
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/20/2024

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: DWP1390
• Device Lot Number: 6368AY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA 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): Other
• Patient Sex: Male