MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II COMBO 36/42 INSERT TH.+9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD989
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
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.
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.

• Brand Name: AEQUALIS REVERSED II COMBO 36/42 INSERT TH.+9MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16792049
• Report Number: 3000931034-2023-00115
• Device Sequence Number: 14879115
• Product Code: KWS
• UDI-Device Identifier: 03700386932748
• UDI-Public: 03700386932748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081059
• 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: DWD989
• Device Catalogue Number: DWD989
• 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