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

Model Number	STD PTC STEM SIZE 3C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On november 10th, 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.Additional devices listed in this report: catalog number dwf148, aequalis ascend flex humeral head 48x18, lot number 5678ap027.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Infection can be related to several reasons: a previous surgery, a sub-acromial dead space, a poor sterile technique, more fragile patients or patients younger than 65 years who have a greater risk.After checking the sterile md release sheets of the complaint parts, no issue has been reported.All concerned results were compliant.No other complaint has been reported since today regarding infections with parts of the same lots implanted and regarding the traceability history of the lots.
Event or Problem Description
It was reported that a patient underwent revision surgery due to infection at 15 days post-op.Antibiotherapy during 6 weeks.Patient id : (b)(6).

• Brand Name: AEQUALIS ASCEND FLEX
• 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: 13606750
• Report Number: 3000931034-2022-00081
• Device Sequence Number: 19325188
• Product Code: KWS
• UDI-Device Identifier: 03700434019728
• UDI-Public: 03700434019728
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: 11/27/2017
• Device Model Number: STD PTC STEM SIZE 3C
• Device Catalogue Number: DWF603C
• Device Lot Number: 9157AL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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: 63 YR
• Patient Sex: Male