MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM ANATOMIC AUG SMALL LEFT KEELED 15 DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWK503LA15
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.
Additional Manufacturer Narrative
Correction - g1.The reported event could not be confirmed since the device was not returned for evaluation.Photos were provided from the complaint reporter; however, the device was covered in biological material and a device inspection was not possible.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that there was a patient underwent a total shoulder replacement.Due to increasing instability in joint over recent months, surgeon decided to convert the tsa to a reverse shoulder replacement.All components were well fixed.The glenoid poly implant had to be broken up in-situ and removed in pieces.The humeral component was extremely well fixed.Significant bone was attached to the central core/fins of the component.A reverse arthroplasty prosthesis was implanted.Stabile range of motion was demonstrated at the conclusion of surgery.

• Brand Name: TORNIER PERFORM ANATOMIC AUG SMALL LEFT KEELED 15 DEG
• 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 MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16744415
• Report Number: 0001649390-2023-00058
• Device Sequence Number: 6540065
• Product Code: KWS
• UDI-Device Identifier: 00846832090556
• UDI-Public: 00846832090556
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Expiration Date: 10/19/2023
• Device Model Number: DWK503LA15
• Device Catalogue Number: DWK503LA15
• Device Lot Number: BP0518149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2018
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 95 KG