MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 1/2, 36MM DIA, +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWP1360
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a revision surgery conducted utilizing the blueprint planning feature.The primary implants used in this case were tornier.The explanted devices included a tornier 36 standard glenosphere and a reversed insert.The revision surgery was necessitated by dislocation, with no accompanying x-rays provided and no notable circumstances surrounding the event.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition is unknown.
Additional Manufacturer Narrative
The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
There was a revision surgery conducted utilizing the blueprint planning feature.The primary implants used in this case were tornier.The explanted devices included a tornier 36 standard glenosphere and a reversed insert.The revision surgery was necessitated by dislocation, with no accompanying x-rays provided and no notable circumstances surrounding the event.

• Brand Name: PERFORM REV INSERT SZ 1/2, 36MM DIA, +0
• Common Device Name: 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: 17568956
• Report Number: 0001649390-2023-00199
• Device Sequence Number: 6796633
• Product Code: PHX
• UDI-Device Identifier: 00846832084395
• UDI-Public: 00846832084395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/10/2026
• Device Catalogue Number: DWP1360
• Device Lot Number: 6828AW007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown