MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPHERE - 18MM; PROSTHESIS, CHIN, INTERNAL

Catalog Number	6327
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after sizing, the corresponding implant was opened but did not fit.Another implant of the same size was opened and used instead.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: h4, h6.Correction: d2a.The reported event that the device did not fit could not be confirmed.Investigation of the returned device verified that the dimensions met specification and dhr review identified no manufacturing discrepancies.Available information indicates that the surgeon selected a smaller implant size during the procedure to achieve the desired fit.Except for a surgical delay of 5 to 10 minutes, no adverse consequences or medical intervention were reported.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: SPHERE - 18MM
• Common Device Name: PROSTHESIS, CHIN, INTERNAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Mahwah; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: elena gehring ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; +49()7614888208
• MDR Report Key: 24510798
• Report Number: 0008010177-2026-00025
• Device Sequence Number: 10486567
• Product Code: FWP
• UDI-Device Identifier: 07613252083405
• UDI-Public: 07613252083405
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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
• Device Catalogue Number: 6327
• Device Lot Number: JL2JL2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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 Sex: Unknown