MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK DIRECTINJECT 10CC; IMPLANT

Catalog Number	79-45910
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	02/29/2024
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 to stryker that the patient began experiencing discomfort four years after the material was inserted.It was reported there was inflammatory reactions and swelling.A post operative scan was performed and showed that the swelling was due to the implant inserted and a revision surgery was performed to remove the implant.
Additional Manufacturer Narrative
The reported event could not be confirmed due to insufficient information.The sales rep stated that "hospital and surgeon policy" prevents further details from being shared.For infection complaints, stryker orthopaedics in (b)(6), ireland, conducts expanded investigations to ensure that the device and related manufacturing processes did not contribute to the event.These investigations, documented in the "infection complaints - checklist investigator" ((b)(4)), found no discrepancies.Currently, there is not enough information to determine the exact root cause of the failure mode.If the product is returned or further details are provided, the complaint will be reopened.Based on the investigation and dhr checks, no design, material, or manufacturing issues were found, so no corrective or preventive actions are necessary at this time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported to stryker that the patient began experiencing discomfort four years after the material was inserted.It was reported there was inflammatory reactions and swelling.A post operative scan was performed and showed that the swelling was due to the implant inserted and a revision surgery was performed to remove the implant.

• Brand Name: DIRECTINJECT 10CC
• 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: 19876295
• Report Number: 0008010177-2024-00074
• Device Sequence Number: 17918057
• Product Code: GXP
• UDI-Device Identifier: 07613327123272
• UDI-Public: 07613327123272
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Catalogue Number: 79-45910
• Device Lot Number: DI18018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male