MAUDE Adverse Event Report: STRYKER GMBH PRESS-FIT HUMERAL STEM 9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5567-P-3009
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that an expired device was implanted into the patient.
Additional Manufacturer Narrative
The reported event could be confirmed.The device expired on 12 november 2025, while the event occurred on (b)(6) 2025.A review of the device history record for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material-, manufacturing-, or design-related issues were identified during the investigation.No product-related issue could be detected.A review of the label verification in the manufacturing documentation confirmed that the expiry date was correctly indicated on the labels.As the device was under stryker consignment at the time it expired, a nonconformity was opened to address the stock-related issue.Nevertheless, it should be noted that the final responsibility lies with the user to verify the expiry date prior to opening the package.In general, it can be stated that once the shelf life has expired, stryker cannot guarantee the performance and safety of the device for use.The risk of infection increases with time elapsed after the expiry date printed on the packaging.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that an expired device was implanted into the patient.

• Brand Name: PRESS-FIT HUMERAL STEM 9MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24132590
• Report Number: 0008031020-2026-00079
• Device Sequence Number: 5455484
• Product Code: KWS
• UDI-Device Identifier: 07613327425017
• UDI-Public: (01)07613327425017(17)251112(10)G7987747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/12/2025
• Device Catalogue Number: 5567-P-3009
• Device Lot Number: G7987747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2020
• 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
• Patient Age: 74 YR
• Patient Sex: Female