MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 36MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5572-4536

Device Problem Loss of Osseointegration (2408)

Patient Problems Inadequate Osseointegration (2646); Osteopenia/ Osteoporosis (2651)

Event Date 02/22/2024

Event Type  Injury  

Event Description

As reported: "peripheral screw pulled through the baseplate locking mechanism.Baseplate was pulled out of patient while one of the peripheral screws remained intact in the patients glenoid." update 04 feb 2024: initial surgery took place on (b)(6) 2021.Surgeon was concerned about calcar bone loss, so modified an implant and cemented a long stem.Standard baseplate and tuberosity repair.Revision surgery details: the glenoid was loose.Glenosphere appeared still on the baseplate, but the screw went through in the soft tissues.Patient was revised to a hemiarthroplasty.Very medically unwell (poor medical status and weird presentation (bone loss - osteoporosis)).Patient could have a neuropathic shoulder from his cervical spine which could explain loosening.Devices successfully removed.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: 4.5MM PERIPHERAL SCREW - 36MM
• Type of Device: 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: 18936402
• MDR Text Key: 338069340
• Report Number: 0008031020-2024-00125
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098761
• UDI-Public: 07613327098761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5572-4536
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose