MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED LATER ALIZED GLENOSPHERE +3 DIA 42MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWJ024
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	03/27/2023
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.H3 other text : device was discarded.
Event or Problem Description
It was reported that the patient underwent left reverse shoulder replacement on (b)(6) 2023.Patient's shoulder dislocated two days later, which was manipulated and a closed reduction achieved.Patient again dislocated their prosthetic shoulder two days later.Decision made to open wound up, and determine cause of instability.Also, patient's wound returned a positive swab for "colonization" according to surgeon.During surgery, multiple tissue specimens were taken, for pathology.An osteophyte of the postero-superior aspect of the proximal humerus was identified as the likely cause of the range of motion impingement, leading to instability / dislocation.This was removed; the glenosphere was exchanged (as there were minor scratches on the polished surface).The 6mm poly was also exchanged for a 9mm poly, which conferred greater stability, and adequately tensioned the joint.Stable range of motion obtained; wound closed.Both explanted prosthesis discarded by scrub nurse.

• Brand Name: TORNIER PERFORM REVERSED LATER ALIZED GLENOSPHERE +3 DIA 42MM
• 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): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16792079
• Report Number: 0001649390-2023-00073
• Device Sequence Number: 5692213
• Product Code: KWS
• UDI-Device Identifier: 00846832090396
• UDI-Public: 00846832090396
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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: DWJ024
• Device Catalogue Number: DWJ024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/21/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG