MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 44 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	DWD144
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Joint Laxity (4526); Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	12/12/2024
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.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Patient underwent primary left reverse shoulder replacement on (b)(6) 2019.Surgeon states that prosthetic joint has been functioning well, until approximately 6 months ago, when patient experienced sudden onset of pain, and increasing instability (patient had been doing exercises with weights).During surgery, prosthetic joint was found to be very lax, easily dislocated, with sub-scapularis tendon ruptured.Surgeon repaired sub-scap., plus tendon graft / repair, then removed the 9mm humeral poly insert, replacing this with a 9mm spacer plus a new 9mm poly insert.Additional information: the locking screw that came with the 36mm spacer, would not engage with the implant.The 42mm spacer was opened to access another locking screw.This screw was found to engage the implanted metaphysis, locking the impacted spacer to the metaphysis.The faulty locking screw is available for return.Joint was found to be stable through full range of movement, soft tissue envelop reconstructed (separate complaint raised for screw).
Event or Problem Description
Patient underwent primary left reverse shoulder replacement on (b)(6) 2019.Surgeon states that prosthetic joint has been functioning well, until approximately 6 months ago, when patient experienced sudden onset of pain, and increasing instability (patient had been doing exercises with weights).During surgery, prosthetic joint was found to be very lax, easily dislocated, with sub-scapularis tendon ruptured.Surgeon repaired sub-scap., plus tendon graft / repair, then removed the 9mm humeral poly insert, replacing this with a 9mm spacer plus a new 9mm poly insert.Additional information - the locking screw that came with the 36mm spacer, would not engage with the implant.The 42mm spacer was opened to access another locking screw.This screw was found to engage the implanted metaphysis, locking the impacted spacer to the metaphysis.The faulty locking screw is available for return.Joint was found to be stable through full range of movement, soft tissue envelop reconstructed (separate complaint raised for screw).
Additional Manufacturer Narrative
Correction - please refer d4 lot.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 44 STERILE
• 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: 21110806
• Report Number: 3000931034-2025-00017
• Device Sequence Number: 21012342
• Product Code: KWS
• UDI-Device Identifier: 03700386917127
• UDI-Public: (01)03700386917127(17)221031(21)3778AS019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: DWD144
• Device Lot Number: 3778AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG