MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 20MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4520
Medical Device Problem Codes	Break (1069); Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported; "surgeon scheduled a revision surgery with the stryker representative.During the surgery, it was determined that the baseplate/screw/glenosphere construct was loose.One screw was broken.The glenoid baseplate/glenosphere/screws were explanted.The cup/poly construct was explanted from the humeral side.A 36mm stryker cup/poly construct was replaced on the humeral stem.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d1 (product long description) and d4 (catalog #).The reported loosening of the construct could not be confirmed in relation to the intact screws based on the received x-ray, therefore is the complaint rated as unconfirmed for the intact screws.The device inspection revealed the following: one intact peripheral screw was returned, the visual inspection has shown that the screw is in a good condition with just slight wear marks that can be traced back to normal use.A visual inspection of the glenosphere bottom surface was made, there are no wear marks from the peripheral screws or the center screw on the surface visible, this indicates that there was no post-operative loosening of the screws.Based on that the reported loosening of the construct can be traced back to the broken screw and not to a loosening of the other screws.A functional test was made with the intact peripheral- and the center screw.Both devices could be locked in the baseplate as required, no functional issue could be observed.A review of the device history was not possible because the lot number was not communicated.However, during the performed evaluation no indications of material, manufacturing or design related problems were found.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No product related issue could be detected, as stated before can the reported loosening be traced back to the broken screw and the returned intact screws can be considered as concomitant devices.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported; "surgeon scheduled a revision surgery with the stryker representative.During the surgery, it was determined that the baseplate/screw/glenosphere construct was loose.One screw was broken.The glenoid baseplate/glenosphere/screws were explanted.The cup/poly construct was explanted from the humeral side.A 36mm stryker cup/poly construct was replaced on the humeral stem.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 20MM
• 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 GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18436509
• Report Number: 0008031020-2024-00004
• Device Sequence Number: 7024291
• Product Code: KWS
• UDI-Device Identifier: 07613327098723
• UDI-Public: 07613327098723
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5572-4520
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/05/2024
• 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: 89 YR
• Patient Sex: Female