MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL STEM SZ 3; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER ADDITIVE, CEMENTED

Catalog Number DWX3SS

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

Patient Problem Pain (1994)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

Device will not be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient is having bilateral incision pain.There are no hardware complications.X-rays at 12 months confirmed no hardware complication.Plan to work up for inflammatory issues, referral to rheumatology, pain clinic and mri of cervical spine to rule out radiculopathy.

Manufacturer Narrative

The reported event could not be 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.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 Description

It was reported that the patient is having bilateral incision pain.There are no hardware complications.X-rays at 12 months confirmed no hardware complication.Plan to work up for inflammatory issues, referral to rheumatology, pain clinic and mri of cervical spine to rule out radiculopathy.

• Brand Name: PERFORM HUMERAL STEM SZ 3
• 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18681633
• MDR Text Key: 335073823
• Report Number: 0001649390-2024-00036
• Device Sequence Number: 1
• Product Code: PAO
• UDI-Device Identifier: 00846832085477
• UDI-Public: 00846832085477
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DWX3SS
• Device Lot Number: AE8934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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
• Patient Age: 70 YR
• Patient Weight: 78 KG