MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BODY - STEM SEPARATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6278-9-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided: it was reported that the patient's left hip was revised due to instability.A ceramic head and adm/ mdm poly insert were revised to a 28+2 metal head with another adm/ mdm poly insert.Intra-operatively, the following occurred: wear of the trunnion was noted.Surgeon attempted to remove the 22 +10 proximal cone body, and while using a mallet on the implant extractor, broke it.Nothing remained in the patient.The bolt from the old cone body was removed, and a bolt from a new cone body was implanted.Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: BODY - STEM SEPARATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24093557
• Report Number: 0002249697-2026-00030
• Device Sequence Number: 10328525
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2026

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: Health Professional
• Device Catalogue Number: 6278-9-070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/16/2026
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 170 KG