MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS ASCEND FLEX HEAD; SHOULDER JOINT METAL PROSTHESIS

Model Number	HUMERAL HEAD HIGH OFFSET 41X15 TI
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Erythema (1840); Rash (2033)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a post-operative complication due to possible monocryl or titanium allergy (erythema/rash at superior incision site).Patient id : (b)(6).
Additional Manufacturer Narrative
On (b)(6) 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.As the description states an erythema "at superior incision site", we may suppose that the event is due to the allergy to the suture component and not to the titanium.Patient condition may be a cause of the event, considering the sensitivity reported in the medical history.

• Brand Name: AEQUALIS ASCEND FLEX HEAD
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 13607060
• Report Number: 3000931034-2022-00088
• Device Sequence Number: 1969715
• Product Code: KWS
• UDI-Device Identifier: 03700386940392
• UDI-Public: 03700386940392
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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 Expiration Date: 01/17/2020
• Device Model Number: HUMERAL HEAD HIGH OFFSET 41X15 TI
• Device Catalogue Number: DWF341
• Device Lot Number: 3330AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 101 KG