MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE PROXIMAL BODY 13DIA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ARS741703
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the patient underwent a revision surgery to convert a hemi arthroplasty to a reverse shoulder arthroplasty.The proximal body was loose upon revision of hemi arthroplasty to reverse shoulder arthroplasty.Proximal body, assembly screw, locking cap and spacer all had to be removed.Short stem had to be cemented on top of distal stem which could not be removed.
Additional Manufacturer Narrative
The reported event could be confirmed, since a medical review of the provided x-rays by a hcp, determined that there was evidence of loosening.The device was returned and identified as item #ars741703; lot #az0419049.The device inspection revealed the following: visual inspection: a visual inspection found slight scuffing on the devices typical of having been used.No other defect or deformations could be observed.Medical expert opinion: since data was provided, the opinion of a medical expert was sought and stated as follows: ¿the x-ray show sclerosis and some osteophyte formation at the glenoid side.There is still some preservation of the joint space indicating residual cartilage is present at the glenoid side.Without an x-ray of the situation before this hemiarthroplasty is not possible to assess if these changes are the result of progressive glenoid erosion.Reasons for pain can be progressive glenoid degeneration, loosening of the revive stem (although it seems to be well-fixed distally), and/or periprosthetic joint infection.Without being able getting information on the retrievals, i cannot assess to what extend the proximal body of the revive stem has loosened before revision surgery.The cementation of the short stem proximal to the distal stem is not without risks.The bone of the proximal humerus is quite thin, and the cement mantle is insufficient to prevent a possible junctional fracture at the transition zone between the distal tip of the short stem and the proximal end of the distal stem.If no other option, cementing the distal tip of a slightly longer stem into the distal stem could have worked out advantageous.Furthermore, the central screw of the glenoid baseplate has missed the body of the glenoid, providing a less optimal fixation.¿ more detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient underwent a revision surgery to convert a hemi arthroplasty to a reverse shoulder arthroplasty.The proximal body was loose upon revision of hemi arthroplasty to reverse shoulder arthroplasty.Proximal body, assembly screw, locking cap and spacer all had to be removed.Short stem had to be cemented on top of distal stem which could not be removed.

• Brand Name: AEQUALIS FLEX REVIVE PROXIMAL BODY 13DIA
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15100098
• Report Number: 0001649390-2022-00041
• Device Sequence Number: 4149476
• Product Code: KWS
• UDI-Device Identifier: 00846832069309
• UDI-Public: 00846832069309
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 Expiration Date: 06/20/2024
• Device Model Number: ARS741703
• Device Catalogue Number: ARS741703
• Device Lot Number: AZ0419049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2019
• 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: 74 YR
• Patient Sex: Female