MAUDE Adverse Event Report: TORNIER INC TORNIER HRS PTC DISTAL STEM DIA 11; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	ARS741802
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Inadequate Osseointegration (2646)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, based on the medical expert opinion and since the product was returned for evaluation and matches the alleged failure mode.A review of the x-rays by the medical expert stated; ¿the device was used as intended but the fracture was not healed indicating non-union.Since the proximal part of the body is not supported by stable bone connected by diaphysis therefore, the proximal body, spacer and screw appears to be untwisted.The reason behind the failure is non-union of proximal humeral fracture.¿ 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 investigation and formal medical expert opinion, the root cause was attributed to patient related issue.The non-union of the proximal humeral fracture led to the disassembly of the components.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "it was reported that a loosening of the components was detected, and it was wearing a locking cap that is supposed to lock the components.After approximately 8 months of initial surgery, the patient noticed a ¿click¿ and they went to the emergency room, where they underwent an x-ray showing the disassembly of the implant.However, it was not until (b)(6) 2024 that they were seen by a traumatologist who knew about the implant and was the one who detected that the condition of the stem was not where it should be.The initial surgery was on (b)(6) 2023 and a torque screwdriver was used to ensure that the tightening torque was done with the necessary force.The initial surgery was completed successfully without anything to report.".

• Brand Name: TORNIER HRS PTC DISTAL STEM DIA 11
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19629097
• Report Number: 0001649390-2024-00289
• Device Sequence Number: 20682792
• Product Code: KWS
• UDI-Device Identifier: 00846832093021
• UDI-Public: 00846832093021
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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 Catalogue Number: ARS741802
• Device Lot Number: AZ3122048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown