MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II DIA29 L30 THREADED POST BASE PLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWE830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
The patient in the tornier shoulder outcomes study developed an infection, specifically p.Acnes.This infection was treated with a 6-week course of intravenous (iv) antibiotics.Following the iv antibiotics, the patient was started on oral suppression therapy with sequelae.
Additional Manufacturer Narrative
The reported event that was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Additionally medical opinion was sought as it involves infection and below is the response received: ¿the device components not being explanted usually means that there was a superficial surgical site infection without the need for (partial) revision.This means the surgeon assumed the implants were not infected, and antibiotic treatment was deemed sufficient.With the information at hand, we can only conclude that most likely the device was not contaminated, and antibiotics were given to treat the superficial infection and protect the implant from that infection.To come back to your question: the infection was not device related.¿ 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 device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The patient in the tornier shoulder outcomes study developed an infection, specifically p.Acnes.This infection was treated with a 6-week course of intravenous (iv) antibiotics.Following the iv antibiotics, the patient was started on oral suppression therapy with sequelae.

• Brand Name: AEQUALIS REVERSED II DIA29 L30 THREADED POST BASE PLATE
• 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): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17762353
• Report Number: 3000931034-2023-00298
• Device Sequence Number: 6617872
• Product Code: KWS
• UDI-Device Identifier: 03700386952739
• UDI-Public: 03700386952739
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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 Expiration Date: 03/24/2019
• Device Catalogue Number: DWE830
• Device Lot Number: 0079AO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 09/17/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: 79 KG