MAUDE Adverse Event Report: STRYKER GMBH GLENOSPHERE - 36MM DIA X 6MM THK CONCENTRIC; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5573-C-3606
Medical Device Problem Codes	Osseointegration Problem (3003); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	10/12/2023
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
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
Additional Manufacturer Narrative
Please note the corrctions made to the d1 manufacturing site, d3 legal manufacturer, and g1 manufacturing site: this device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.
Additional Manufacturer Narrative
Correction: h6 (results & conclusion codes), correct fda registration number as: 9610622 - te (kiel) this device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
The surgeon scheduled a revision surgery with a stryker representative.During the surgery, it was found that the baseplate/screw/glenosphere construct was loose, with two of the four screws not contained within the construct.The glenoid baseplate/glenosphere/screws and the cup/poly construct were removed.A 40mm humeral head was attached to the existing humeral stem.The indication for the primary procedure was a fracture.The revision surgery was successful.

• Brand Name: GLENOSPHERE - 36MM DIA X 6MM THK CONCENTRIC
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach MN 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: 18096787
• Report Number: 0001649390-2023-00306
• Device Sequence Number: 12417604
• Product Code: KWS
• UDI-Device Identifier: 07613327098891
• UDI-Public: 07613327098891
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5573-C-3606
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 01/24/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/21/2023; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5 YR
• Patient Sex: Female