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

Model Number HUMERAL HEAD HIGH OFFSET 41X15 TI

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Rash (2033)

Event Date 11/01/2017

Event Type  Injury  

Event 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).

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
• Type of Device: 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
• MDR Text Key: 289666397
• Report Number: 3000931034-2022-00088
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386940392
• UDI-Public: 03700386940392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 101 KG