MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number DWJ013

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

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Paralysis (1997); Loss of Range of Motion (2032)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.

Event Description

It was reported the patient was seen on for standard of care follow-up visit.The treating surgeon did not feel a strong contraction in the axillary nerve.Patient could not hold arm in abduction against gravity.Deltoid contraction was minimal.Patient will complete normal physical therapy plan.

Event Description

It was reported the patient was seen on for standard of care follow-up visit.The treating surgeon did not feel a strong contraction in the axillary nerve.Patient could not hold arm in abduction against gravity.Deltoid contraction was minimal.Patient will complete normal physical therapy plan.

Manufacturer Narrative

The reported event could be not be confirmed.The device remains implanted and no other evidences were provided that could confirm the allegation.The opinion of the medical expert was requested and stated as following: ¿this axillary nerve dysfunction, that leads to a deltoid muscle weakness is indeed an ae that is not device related yet related to the surgery.Usually it¿s neuropraxia (traction injury without loss of structural nerve continuity) and will resolve spontaneously, but sometimes it doesn¿t, or it doesn¿t completely when the nerve is damaged more severely.It will become clear during follow up.Sometimes electrophysiological investigation, assessing the conduction velocity of the nerve(s) at 6 weeks after the problem started, may provide a recovery prognosis.¿ a device inspection was not possible since the affected device was not returned as it remains implanted in the patient.A review of the labeling and 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.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED STAND ARD GLENOSPHERE DIA 39MM
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16210737
• MDR Text Key: 307745496
• Report Number: 0001649390-2023-00018
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832090341
• UDI-Public: 00846832090341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DWJ013
• Device Catalogue Number: DWJ013
• Device Lot Number: AE9459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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