MAUDE Adverse Event Report: TORNIER INC PERFORM FX STEM SZ 11 L. 130MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	PFX11130
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient, who had a history of a four-part proximal humerus fracture, underwent reverse total shoulder arthroplasty.The humeral stem became loose, which was confirmed by radiographs.As a result, a revision surgery was performed to remove and replace the loose humeral stem with a different stem that was not part of the perform fracture system.
Event or Problem Description
It was reported that the patient, who had a history of a four-part proximal humerus fracture, underwent reverse total shoulder arthroplasty.The humeral stem became loose, which was confirmed by radiographs.As a result, a revision surgery was performed to remove and replace the loose humeral stem with a different stem that was not part of the perform fracture system.
Additional Manufacturer Narrative
The reported event was confirmed, since x-rays of the event were provided and match the alleged failure mode.The device inspection revealed the following: an evaluation of the post operative x-rays reveals loosening of the humeral component of the implant that used a cementless and screwless fixation method.However, all implant components remain structurally intact.The investigation did not reveal a clear root cause.Insufficient information prevents a definitive assessment of the reasons behind the loosening of the humeral stem.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM FX STEM SZ 11 L. 130MM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 20081832
• Report Number: 0001649390-2024-00401
• Device Sequence Number: 7590360
• Product Code: KWT
• UDI-Device Identifier: 00846832092369
• UDI-Public: 00846832092369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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 Catalogue Number: PFX11130
• Device Lot Number: 2828AZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 73 KG