MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 4 PLUS LONG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX4PL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/05/2024
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
After undergoing revision surgery, the patient became infected, leading to the removal of all implants.The infection was discovered by the surgeon, localized in the shoulder joint.The surgery to remove the implants occurred shortly afterward.Microorganisms were not identified, and there was no prior infection near the surgical site.The sterile barrier of the device package remained intact, and no re-sterilization was performed before surgery.No environmental monitoring alerts were recorded before the surgery.The infection was reported by the surgeon, who then proceeded to remove all implants and insert a cement spacer.
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.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention, and the aftercare.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
After undergoing revision surgery, the patient became infected, leading to the removal of all implants.The infection was discovered by the surgeon, localized in the shoulder joint.The surgery to remove the implants occurred shortly afterward.Microorganisms were not identified, and there was no prior infection near the surgical site.The sterile barrier of the device package remained intact, and no re-sterilization was performed before surgery.No environmental monitoring alerts were recorded before the surgery.The infection was reported by the surgeon, who then proceeded to remove all implants and insert a cement spacer.

• Brand Name: PERFORM HUMERAL STEM SZ 4 PLUS LONG
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, 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: 19231734
• Report Number: 0001649390-2024-00219
• Device Sequence Number: 6834297
• Product Code: PAO
• UDI-Device Identifier: 00846832085491
• UDI-Public: 00846832085491
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: DWX4PL
• Device Lot Number: AF6345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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 Sex: Unknown