MAUDE Adverse Event Report: TORNIER INC ASCEND HUMERAL HEAD CENTERED DIA.44MM H. 17MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	502344
Medical Device Problem Codes	Unstable (1667); Migration (4003)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/16/2022
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to loosening/ lysis.The following were removed stem tornier ascend: 5a standard ptc humeral stem , humeral head tornier ascend : 44 x 17 low offset ascend, and the glenoid tornier perform cortiloc.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to loosening/ lysis.The following were removed stem tornier ascend: 5a standard ptc humeral stem , humeral head tornier ascend : 44 x 17 low offset ascend, and the glenoid tornier perform cortiloc.
Additional Manufacturer Narrative
Please note the corrections to the fda registration number (0001649390 - bloomington) and the d3 manufacturer entity: the reported event was not 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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No indications of material, manufacturing or design related problems were found during the investigation.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: ASCEND HUMERAL HEAD CENTERED DIA.44MM H. 17MM
• 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: 16280368
• Report Number: 3000931034-2023-00043
• Device Sequence Number: 6522690
• Product Code: KWS
• UDI-Device Identifier: 00846832004102
• UDI-Public: 00846832004102
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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 Model Number: 502344
• Device Catalogue Number: 502344
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG