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

Catalog Number	DWP2390
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Product not returned, lost during transit the reported event was confirmed, based on the medical opinion on the provided x-ray.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 & design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by heavy weightlifting which is not intended during post operative care.The product was lost/not returned.A nonconformance was opened to investigate further what are the root causes.If the product is found, the investigation will be reopened and reworked.If any further information is provided, the complaint report will be updated.
Event or Problem 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.

• Brand Name: PERFORM REV INSERT SZ 3/4 39MM 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: 19120377
• Report Number: 0001649390-2024-00162
• Device Sequence Number: 15516054
• Product Code: PHX
• UDI-Device Identifier: 00846832084487
• UDI-Public: 00846832084487
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/11/2025
• Device Catalogue Number: DWP2390
• Device Lot Number: 9145AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2020
• 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 Age: 77 YR
• Patient Sex: Unknown