MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 28MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4528
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.
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
Please note correction to d1 (product long description) and d4 (catalog #) the reported event could be confirmed, since one screw is broken, which is also visible on the received x-ray.The device inspection revealed the following: one broken peripheral screw, including the shaft fragment was returned.A microscopic inspection of the fracture face of the broken screw was performed.The typical characteristics of a fatigue fracture could be identified on the fracture face.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.The shiny surface indicates that the fragments rubbed together after breaking.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.The fracture face is homogenous, which indicates material conformity, the relevant dimensions are within the specification and and the relevant design features have been in effect for years.Based on that, it can be concluded that there are no indications of material, manufacturing or design related problems.The complaint was forwarded to medical affairs for review with following feedback: "in this case, the implant either didn¿t osseo integrate well, or lost osseintegration over time.In those case, screw breakage may be inevitable (like in osteosynthesis).The bone looks very dense (sclerotic), which is not favorable for osseintegration.Also, it was placed relatively high onto the glenoid surface making it prone for notching.All together patient related (bone too dense) and possible surgeon related (relatively high positioning on glenoid), may have contributed to this case." based on the available information it is not possible to define the root cause of the fatigue breakage of the peripheral screw.There are several points that could have contributed to the event, but more detailed information, like pre-, intra- and post-operative x-rays in different planes, operation reports, patient details and history and as well the lot number of the screw must be available for a complete assessment.If more information is provided, the case will be reassessed.Device disposition unknown.

• Brand Name: 4.5MM PERIPHERAL SCREW - 28MM
• 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: 18436493
• Report Number: 0008031020-2024-00003
• Device Sequence Number: 12518502
• Product Code: KWS
• UDI-Device Identifier: 07613327098747
• UDI-Public: 07613327098747
• 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: 5572-4528
• 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