MAUDE Adverse Event Report: TORNIER INC TORNIER HRS SPACER 9MM DIA 20MM LENGTH; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	ARS342001
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 the distal humerus only and no evidence on xr of any shoulder joint issue.
Additional 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.
Event or Problem 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.

• Brand Name: TORNIER HRS SPACER 9MM DIA 20MM LENGTH
• Common Device Name: 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: 19159479
• Report Number: 0001649390-2024-00177
• Device Sequence Number: 7833805
• Product Code: HSD
• UDI-Device Identifier: 00846832092581
• UDI-Public: 00846832092581
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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 Expiration Date: 02/15/2025
• Device Catalogue Number: ARS342001
• Device Lot Number: AZ0419310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2020
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG