MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWJ505
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
Patient underwent primary operation on (b)(6) 2023.Had increasing pain in operated shoulder and sought medical advice with non-primary surgeon.X-rays and ct scans showed baseplate was not fixed to scapular and was sitting within the joint.Also showed significant bone loss to remaining glenoid.Decision made to revise implant.Original implants removed.Bone loss too significant to do a single stage revision.Primary fixation of implant not achieved by primary surgeon.Loose implant caused significant bone loss in glenoid.Revision surgery required (multiple stages).
Additional Manufacturer Narrative
Correction - please refer h6 device code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device 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.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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient underwent primary operation in (b)(6) 2023.Had increasing pain in operated shoulder and sought medical advice with non-primary surgeon.X-rays and ct scans showed baseplate was not fixed to scapular and was sitting within the joint.Also showed significant bone loss to remaining glenoid.Decision made to revise implant.Original implants removed.Bone loss too significant to do a single stage revision.Primary fixation of implant not achieved by primary surgeon.Loose implant caused significant bone loss in glenoid.Revision surgery required (multiple stages).

• Brand Name: TORNIER PERFORM REVERSED FULL WEDGE BP 15 DG DIA 25MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21698101
• Report Number: 0001649390-2025-00170
• Device Sequence Number: 12928584
• Product Code: KWS
• UDI-Device Identifier: 00846832092109
• UDI-Public: (01)00846832092109(11)231021(17)281021(10)9138AZ029
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ505
• Device Lot Number: 9138AZ
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2023
• 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: 59 YR
• Patient Sex: Female