MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED II DIA25 L30 THREADED POST BASE PLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWE730
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a left reverse shoulder implanted in approximately 2019.The glenoid baseplate component of the system became loose over time.The glenoid component of the system was removed without issue and the implant was converted to a hemi shoulder with the poly removed on the humeral side and replaced with a convertor and humeral head.
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 on a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that the patient had a left reverse shoulder implanted in approximately 2019.The glenoid baseplate component of the system became loose over time.The glenoid component of the system was removed without issue and the implant was converted to a hemi shoulder with the poly removed on the humeral side and replaced with a convertor and humeral head.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was not returned for evaluation but an x-ray was provided for review.However, the x-ray did not provide conclusive confirmation of the issue noted in this complaint.Since an x-ray was provided, the opinion of the medical expert was requested and stated as following: "it shows the conversion of the reversed stem to the hemi-stemmed option.The glenoid had the remnants of the markers that once belonged to a polyethene glenoid component, and there is marked bone loss at the glenoid side.Partly it is the area where the loosened reverse baseplate was situated.It is not reliable to assess bone quality on one revision x-ray, since many of the bone changes belong to the former implants that were revised.Still we can follow what the surgeon reported on the poor bone quality, loosening of several implants on both shoulders, leading to multiple revisions".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.However, based on the provided information ("(.) it was suggested [by the surgeon] that the patient had poor quality bone as this has happened with other implants in the past"), it is unlikely that the reported event could have been caused by the prosthesis.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS REVERSED II DIA25 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 38330 ; EI 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14606044
• Report Number: 3000931034-2022-00240
• Device Sequence Number: 4346714
• Product Code: KWS
• UDI-Device Identifier: 03700386952661
• UDI-Public: 03700386952661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DWE730
• Device Catalogue Number: DWE730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female