MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 29MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWJ515
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2024
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 the locking mechanism came off when surgeon was tightening the locking screw.The surgeon tried to re-insert the metal ring into the baseplate but was unable.Surgeon had to remove 3 peripheral screws, central screw and baseplate already in place and put in a new implant.This was a second revision surgery for the patient.Surgeon had to use bone graft to compensate for bone lost on the glenoid side when removing the original baseplate.Most of the bone graft was lost when surgeon had to remove the defective baseplate, decreasing the occurrence of successful bone integration.
Event or Problem Description
It was reported that the locking mechanism came off when surgeon was tightening the locking screw.The surgeon tried to re-insert the metal ring into the baseplate but was unable.Surgeon had to remove 3 peripheral screws, central screw and baseplate already in place and put in a new implant.This was a second revision surgery for the patient.Surgeon had to use bone graft to compensate for bone lost on the glenoid side when removing the original baseplate.Most of the bone graft was lost when surgeon had to remove the defective baseplate, decreasing the occurrence of successful bone integration.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection- the returned device was visually examined, and it was found that the capture ring had come out of the peripheral screw hole.There are visible scratches around the hole, suggesting rough usage.Additionally, the geometric shape of the baseplate is misaligned, indicating that the capture ring likely detached from that area.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, the root cause was attributed to a user related issue.The failure was caused due to improper usage of the device.If any further information is provided, the complaint report will be updated.

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 29MM
• 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: 21018035
• Report Number: 0001649390-2024-00731
• Device Sequence Number: 6866711
• Product Code: KWS
• UDI-Device Identifier: 00846832092147
• UDI-Public: (01)00846832092147(11)240331(17)290331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DWJ515
• Device Lot Number: 6280BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2024
• 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: 62 YR
• Patient Sex: Male