MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK 5CC HYDROSET INJECTABLE CEMENT; IMPLANT

Model Number	79-43905
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
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 hcp that the hydroset had disintegrated in the patient and the patient underwent a revision surgery.There is no further information known at this time.

• Brand Name: 5CC HYDROSET INJECTABLE CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• MDR Report Key: 11811758
• Report Number: 0008010177-2021-00028
• Device Sequence Number: 1390001
• Product Code: GXP
• UDI-Device Identifier: 07613154275007
• UDI-Public: 07613154275007
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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
• Operator of Device: No Information
• Device Model Number: 79-43905
• Device Catalogue Number: 79-43905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention