MAUDE Adverse Event Report: STRYKER CORP./HOWMEDICA OSTEONICS CORP SLEEVE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 17-0000E

Patient Problems Cyst(s) (1800); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Scar Tissue (2060); Vomiting (2144); Joint Dislocation (2374); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Reporter calling, stating she has had numerous health problems after she was implanted with the "biolox" hip from stryker "some time in 2019".Reporter states she learned that her implanted hip system was "recalled" and she has concerns that her health problems are due to this.Reporter states she has memory problems, pain, headaches, nausea and vomiting, hip dislocating after surgery, and a "cyst or tumor around the hip" currently.Reporter states she additionally has problems walking, has scar tissue, and bone loss.Reporter states she is concerned that the metal in the hip devices is negatively interacting with her body somehow.Reporter additionally states she has concerns about "quality problems" with the mako system that was used during her surgery.Reporter states she is trying to obtain additional records from her doctor's office.Reference reports: mw5149919, mw5149920, mw5149921, mw5149922.

• Brand Name: SLEEVE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER CORP./HOWMEDICA OSTEONICS CORP
• MDR Report Key: 18474398
• MDR Text Key: 332657551
• Report Number: MW5149918
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/08/2024

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?: Yes
• Device Model Number: 17-0000E
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Patient Sequence Number: 1
• Treatment: BIOLOX FEMORAL HEAD.; MAKO TKA SYSTEM.; MDM LINER.; X3 INSERT.
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Female