MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MEDPOR TITAN OFW - MTB - RIGHT - 1.0MM; IMPLANT

Catalog Number	81032
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
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
It was reported by the distributor that the packaging was found empty upon opening and the nurse opened another pack to complete the case.
Additional Manufacturer Narrative
Additional information: h3, h4, h6.Device evaluation: follow up report submitted to document device evaluation results.The reported event could be confirmed.However, it could not be confirmed that the device was missing within, as the package was already opened at the time of inspection.An empty package was returned with a broken seal and missing inner pouch and device.No adverse clinical impact occurred.Evaluation by stryker mahwah and a dhr review found no manufacturing or packaging deviations, making a manufacturing cause unlikely.The root cause could not be determined.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.
Event or Problem Description
No new information.

• Brand Name: MEDPOR TITAN OFW - MTB - RIGHT - 1.0MM
• Common Device Name: IMPLANT
• 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 drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 23512830
• Report Number: 0008010177-2025-00152
• Device Sequence Number: 9667210
• Product Code: FWP
• UDI-Device Identifier: 07613252084334
• UDI-Public: 07613252084334
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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 Catalogue Number: 81032
• Device Lot Number: 2K6LVE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown