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

Catalog Number DWX2SS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 02/07/2024

Event Type  Injury  

Event Description

Subject reports experiencing numbness in fingers, accompanied by decreased sensation and weakness in the thumb, index, and middle fingers.

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.

• Brand Name: PERFORM HUMERAL STEM SZ 2
• Type of Device: 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
• MDR Text Key: 337234247
• Report Number: 0001649390-2024-00103
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832085439
• UDI-Public: 00846832085439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWX2SS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 105 KG