MAUDE Adverse Event Report: STRYKER GMBH BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	5572-2800
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that reunion baseplate/glenosphere/ screws became loose after revision surgery.Screws look to have worked themselves through baseplate on glenoid side full removal of glenoid parts and hemi head implanted.The patient underwent a revision surgery.
Event or Problem Description
It was reported that reunion baseplate/glenosphere/ screws became loose after revision surgery.Screws look to have worked themselves through baseplate on glenoid side full removal of glenoid parts and hemi head implanted.The patient underwent a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the returned baseplate was blocked in the glenosphere along with the screws and could not be disassembled.The baseplate is heavily worn out and deformed.It was not possible to determine if the deformation and wear observed happened while the device was still implanted and are related to the reported loosening or if they happened during the explantation.Note: it was not deemed necessary to disassemble the devices since having a view of the "entire" beseplate would not have given any further information.Furthermore, since it could be determined that the baseplate was most likely not the cause of the reported event and since no abnormal wear was observed on the implant, the lot # of the device would not have given any information crucial to the investigation.A late post-operative x-ray was received and was inspected by a medical expert, who stated the following: "the x-ray confirms the loosening and upward migration of the glenoid component.Please note that there are no x-rays available for comparison to the early- postoperative position of the implant.The segmental damage to the polyethylene insert may very well be related to joint instability and subluxations, however, it is not possible to assess whether this was an initial issue and played a role in loosening, or that is started to happen after loosening of the implant.Without further information it is not possible to make a definitive assessment, and i¿ll refrain from other (theoretical) scenarios.At this point, i tend to patient-related factors a cause of loosening." based on the inspection performed and the opinion of the medical expert, the root cause was attributed to a patient related issue.A review of the device history was not possible because the lot number was not identified.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number could not be identified.If more information is provided, the case will be reassessed.

• Brand Name: BASEPLATE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17101784
• Report Number: 0008031020-2023-00219
• Device Sequence Number: 12715946
• Product Code: KWS
• UDI-Device Identifier: 07613327098709
• UDI-Public: 07613327098709
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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 Model Number: 5572-2800
• Device Catalogue Number: 5572-2800
• Device Lot Number: UNKNOWN
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 82 KG