MAUDE Adverse Event Report: TORNIER INC TORNIER HRS SPACER 9MM DIA 30MM LENGTH; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS342007
Medical Device Problem Codes	Loss of Osseointegration (2408); Biocompatibility (2886)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
A revision surgery was required following the disengagement of the tray from the revive stem in an active, independently mobile patient who presented with acute shoulder pain.Intraoperative findings revealed a loose stem, failure at the morse taper interface, pseudomembrane formation around the tray, and significant metallosis.The stem, tray, and liner were revised using a larger stem size, while the glenosphere and screws remained intact due to stable fixation.Postoperatively, the patient underwent standard rehabilitation, including sling immobilization for 3 to 4 weeks followed by gentle mobilization under physiotherapy supervision.X-ray images are not included due to patient confidentiality.
Event or Problem Description
A revision surgery was required following the disengagement of the tray from the revive stem in an active, independently mobile patient who presented with acute shoulder pain.Intraoperative findings revealed a loose stem, failure at the morse taper interface, pseudomembrane formation around the tray, and significant metallosis.The stem, tray, and liner were revised using a larger stem size, while the glenosphere and screws remained intact due to stable fixation.Postoperatively, the patient underwent standard rehabilitation, including sling immobilization for 3 to 4 weeks followed by gentle mobilization under physiotherapy supervision.X-ray images are not included due to patient confidentiality.
Additional Manufacturer Narrative
Correction to h3 (device evaluated by mfg).The reported event could not be confirmed, since the product was returned for evaluation and function as intended without any abnormalities.The device inspection revealed the following: the visual inspection of the devices reveals that majorly the tray component tray is significantly scratched and dented.There is also some fretting marks on the morse taper, most likely as a result of explantation.Furthermore, a functional test of the returned tray and the stem construct was performed and both the components mated as intended.Furthermore, a formal medical expert opinion as well as r&d opinion revealed the following the root cause of failure cannot be determined due to lack of essential clinical and radiological information.Without details on the patient¿s condition and physician assessment, no meaningful clinical evaluation is possible.The morse taper shows consistent form and fit, with no internal damage.Possible causes include a machining defect inadequate bone reaming, or stem instability, but without imaging, these remain speculative¿rendering the investigation inconclusive.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.Based on the investigation a definitive root cause could not be established due to insufficient information.To accurately determine the cause of failure post-operative x-ray of the device is required.If any further information is provided the complaint report will be updated.

• Brand Name: TORNIER HRS SPACER 9MM DIA 30MM LENGTH
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22649365
• Report Number: 0001649390-2025-00536
• Device Sequence Number: 15623641
• Product Code: KWS
• UDI-Device Identifier: 00846832069347
• UDI-Public: (01)00846832069347(17)250424(21)AZ7019290006
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/24/2025
• Device Catalogue Number: ARS342007
• Device Lot Number: AZ7019290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 137 KG