MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 2; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED

Catalog Number	DWX2SS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject reports experiencing numbness in fingers, accompanied by decreased sensation and weakness in the thumb, index, and middle fingers.
Additional Manufacturer Narrative
The reported event was not confirmed, based on the available x-ray and medical expert opinion.The device inspection was not possible as the product was not returned for investigation.A review of the x-rays by the medical expert stated; ¿the alleged failure relates to sensory loss in the area of the median nerve.Since the device is intact, there is no device related problem.Since no timeline is given, and there is no mentioning of motor-loss, this event does not necessarily has to be related to the procedure.(i.E., carpal tunnel syndrome at the level of the wrist).In order to determine reason behind the alleged failure a more detailed information on timeline would be required.¿ the device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the patient and event must be available in order to determine the exact root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Subject reports experiencing numbness in fingers, accompanied by decreased sensation and weakness in the thumb, index, and middle fingers.
Additional Manufacturer Narrative
Correction: h6 health code the reported event was not confirmed, based on the available x-ray and medical expert opinion.The device inspection was not possible as the product was not returned for investigation.A review of the x-rays by the medical expert stated; ¿the alleged failure relates to sensory loss in the area of the median nerve.Since the device is intact, there is no device related problem.Since no timeline is given, and there is no mentioning of motor-loss, this event does not necessarily has to be related to the procedure.(i.E., carpal tunnel syndrome at the level of the wrist).In order to determine reason behind the alleged failure a more detailed information on timeline would be required.¿ the device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the patient and event must be available in order to determine the exact root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: PERFORM HUMERAL STEM SZ 2
• 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): 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: 18867206
• Report Number: 0001649390-2024-00103
• Device Sequence Number: 7879604
• Product Code: PAO
• UDI-Device Identifier: 00846832085439
• UDI-Public: 00846832085439
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: DWX2SS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 105 KG