MAUDE Adverse Event Report: TORNIER INC ASCEND HUMERAL STEM SIZE 4C BOM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	503304C
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
A two-staged revision surgery was performed, involving the removal of an ascend stem with humeral head and glenoid perform poly due to reported pain by the patient on the right side.The procedure utilized a revive extraction set.
Additional Manufacturer Narrative
The reported event was not confirmed since no other evidences than the returned devices were provided.The two humeral devices were returned for investigation without the glenoid device.On the humeral stem and head, large and deep traces and scratches are observed, probably done when extracting the devices.The head/stem press-fit still works (after 10 years of use).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
A two-staged revision surgery was performed, involving the removal of an ascend stem with humeral head and glenoid perform poly due to reported pain by the patient on the right side.The procedure utilized a revive extraction set.
Additional Manufacturer Narrative
Correction: b5 event description.H3 device evaluated by mfg.H.6 device code, clinical signs code.The reported event was not confirmed since no other evidences than the returned devices were provided.The two humeral devices were returned for investigation without the glenoid device.On the humeral stem and head, large and deep traces and scratches are observed, probably done when extracting the devices.The head/stem press-fit still works (after 10 years of use).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The most probably cause is loosening but more detailed information about the complaint event must be available in order to determine a clear root cause.If more information is provided, the case will be reassessed.
Event or Problem Description
A two-staged revision surgery was performed, involving the removal of an ascend stem with humeral head and glenoid perform poly due to reported pain by the patient on the right side.The procedure utilized a revive extraction set.The reason for the initial revision was implant loosening.

• Brand Name: ASCEND HUMERAL STEM SIZE 4C BOM
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18117860
• Report Number: 0001649390-2023-00312
• Device Sequence Number: 17896627
• Product Code: KWS
• UDI-Device Identifier: 00846832004508
• UDI-Public: 00846832004508
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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: 07/31/2016
• Device Catalogue Number: 503304C
• Device Lot Number: AJ3011174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 09/20/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/26/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2011
• 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