MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 32 STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWD132
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	06/27/2024
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.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 in a supplemental report.
Event or Problem Description
As reported: "patient underwent primary right shoulder replacement, on (b)(6) 2024 hospital, qld.Patient underwent revision of this shoulder joint, yesterday (27.6.24), after a short history of pain, swelling, redness over surgical site.Pt presented at (b)(6)hospital last friday (21.6.24), with these signs, and feeling generally unwell.Clinical diagnosis of infection, as per surgeon's comments yesterday (same surgeon).Revision surgery yesterday carried out at sunshine coast university hospital.Wound opened, multiple specimens taken as several implants were removed and replaced, after copious lavage / debridement.Humeral tray and poly replaced.Ascend flex stem left insitu (appeared to be solidly fixed).Glenosphere replaced.3 of the 4 baseplate screws replaced (4th screw unable to be removed).Baseplate left insitu - very slight movement of baseplate noted, after the 3 x screws removed, but surgeon decided to leave it insitu, and after the new screws were implanted, the baseplate appeared solidly fixed.
Additional Manufacturer Narrative
Correction: please refer to section h6 method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A device inspection was not possible since the affected device was not returned for investigation.As it was not possible to know which of the two multidirectional screws was explanted, a review of the device history was carried out for the both lots provided (4088az070 or 0985ay057) and 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 exact root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "patient underwent primary right shoulder replacement, on (b)(6) 2024, at (b)(6) hospital, qld.Patient underwent revision of this shoulder joint, yesterday on (b)(6) 2024), after a short history of pain, swelling, redness over surgical site.Pt presented at (b)(6) hospital last friday on (b)(6) 2024), with these signs, and feeling generally unwell.Clinical diagnosis of infection, as per surgeon's comments yesterday (same surgeon).Revision surgery yesterday carried out at (b)(6) hospital.Wound opened, multiple specimens taken as several implants were removed and replaced, after copious lavage / debridement.Humeral tray and poly replaced.Ascend flex stem left insitu (appeared to be solidly fixed).Glenosphere replaced.3 of the 4 baseplate screws replaced (4th screw unable to be removed).Baseplate left insitu - very slight movement of baseplate noted, after the 3 x screws removed, but surgeon decided to leave it insitu, and after the new screws were implanted, the baseplate appeared solidly fixed.".

• Brand Name: AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 32 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: 19810359
• Report Number: 3000931034-2024-00389
• Device Sequence Number: 20930087
• Product Code: KWS
• UDI-Device Identifier: 03700386917103
• UDI-Public: 03700386917103
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: DWD132
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 85 KG