MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-LIMERICK HYDROSET INJECTABLE CEMENT KIT 15CC; IMPLANT

Catalog Number	397015
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2018
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.Device cannot be sterilized so returning is not an option.
Event or Problem Description
It was reported that patient's right hip was revised.As reported by rep: "patient had an infection and had some components exchanged during the i and d".
Additional Manufacturer Narrative
The reported event could not be confirmed, because the complained device was not returned for investigation and not enough information was provided.In order to obtain more details about the reported event and determine a complaint root cause the sales rep was contacted.It was stated that due to ¿hospital and surgeon policy¿ no further information will be available.Therefore also the checklist ¿infection complaints ¿ checklist customer¿ (cmfqf 13-003) could not be completed.This document is sent out by default to customers in case of infection complaints to provide more details about the event and to support the determination of the root cause.For infection complaints expanded investigations are performed at the manufacturing site stryker orthopaedics in limerick (ireland) to assure that neither the complained device nor all related manufacturing process steps (e.G.Environmental monitoring, sterilization validations tests) have caused or contributed to the reported event.Furthermore it is evaluated if the risk assumptions in the related fmea are in correspondence with the reported event.All results of this expanded investigation were documented within the ¿infection complaints - checklist investigator¿ (cmfqf 13-002).No discrepancies were found.In the present case the available information was not sufficient enough to determine the exact root cause for the failure mode.In accordance to the related risk management file possible root causes could be: ¿ expired shelf-life ¿ sterile barrier compromised ¿ inappropriate packaging ¿ inappropriate handling by hcp, for example resterilisation ¿ environmental conditions (heat, moisture, pressure) ¿ product damaged (e.G.During shipping) ¿ environmental conditions (heat, moisture, pressure or delivery device exposed to mri with unknown implications) ¿ injecting other liquids not supplied with package with cement ¿ desiccant material (silica gel) gets implanted with product(hydroset 1 only) ¿ other materials are added to the cement before application to patient ¿ 1808: application of liquid without mixing with powder ¿ excessive forces (e.G.Moving, positioning, holding) ¿ moist sterilization results in delaminated glass ¿ eo sterilization results in residuals present in liquid based on investigation including a dhr check and an expanded investigation at the manufacturing site there is no indication for any systematic design, material or manufacturing related issue.Therefore no further corrective and/or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.
Event or Problem Description
It was reported that patient's right hip was revised.As reported by rep: "patient had an infection and had some components exchanged during the i and d".

• Brand Name: HYDROSET INJECTABLE CEMENT KIT 15CC
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• MDR Report Key: 7633657
• Report Number: 0008010177-2018-00055
• Device Sequence Number: 2221798
• Product Code: GXP
• UDI-Device Identifier: 07613154272136
• UDI-Public: 07613154272136
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 397015
• Device Lot Number: VB5S7
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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
• Patient Age: 76 YR