MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED ECCENTRIC GLENOSPHERE +3MM DIA 39MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	DWJ033
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Osteopenia/ Osteoporosis (2651)
Date of Event	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
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.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.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.
Event or Problem Description
Bony resorption along the greater tuberosity and an enlarging effusion around the proximal humerus were observed.A revision surgery was conducted, removing components such as the tray, stem, glenosphere, and insert.The relatedness to the study device was definite, while its relation to the surgical procedure was considered possible.

• Brand Name: TORNIER PERFORM REVERSED ECCENTRIC GLENOSPHERE +3MM DIA 39MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 18961994
• Report Number: 0001649390-2024-00120
• Device Sequence Number: 20873389
• Product Code: PHX
• UDI-Device Identifier: 00846832090419
• UDI-Public: 00846832090419
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024

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: DWJ033
• Device Lot Number: 0304AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG