MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 20MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number ARS655102

Device Problem Osseointegration Problem (3003)

Patient Problems Rheumatoid Arthritis (1724); Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 03/27/2024

Event Type  Injury  

Event Description

Removal of flex revive stem and wires and replacement with cement spacer due to distal humeral (likely) infection and prosthetic loosening.The patient has ra and a bone density deficiency.The revive stem was used to stabilize the displaced distal humerus and cables used to secure the bone.There was evidence of loosening of the distal humerus only and no evidence on xr of any shoulder joint issue.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device was retained by the hospital.

Event Description

Removal of flex revive stem and wires and replacement with cement spacer due to distal humeral (likely) infection and prosthetic loosening.The patient has ra and a bone density deficiency.The revive stem was used to stabilize the displaced distal humerus and cables used to secure the bone.There was evidence of loosening of the distal humerus only and no evidence on xr of any shoulder joint issue.

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.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.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 20MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 19160110
• MDR Text Key: 340792592
• Report Number: 0001649390-2024-00178
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093267
• UDI-Public: 00846832093267
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181420
• 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: 04/22/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: ARS655102
• Device Lot Number: AZ4221354
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/22/2024
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG