MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT ON DEMAND HA CEMENT; IMPLANT

Model Number	79-45905
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post operatively, there was noticeable sinking from the skull.No other information is available at this time.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : discarded.
Event or Problem Description
It was reported that post operatively, there was noticeable sinking from the skull.No other information is available at this time.
Additional Manufacturer Narrative
The bone cement broke postoperatively and was discarded after being removed in a revision surgery a visual, functional, and dimensional inspection was not performed.It was stated that the bone cement broke into fragments postoperatively and the bone fragments had been removed in a revision surgery.Intraoperative pictures or postoperative ct scans and or x-rays were not available for further investigation.H3 other text : discarded.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 17325421
• Report Number: 0008010177-2023-00051
• Device Sequence Number: 6319251
• Product Code: GXP
• UDI-Device Identifier: 07613327123265
• UDI-Public: 07613327123265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: Health Professional
• Device Model Number: 79-45905
• Device Catalogue Number: 79-45905
• Device Lot Number: DI22257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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: Other
• Patient Sex: Unknown