MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG DIRECTINJECT ON DEMAND HA CEMENT; IMPANT

Catalog Number	79-45910
Health Effect - Clinical Code	Reaction (2414)
Date of Event	10/03/2018
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.
Event or Problem Description
It was reported that the patient underwent surgery in (b)(6) 2017 - direct inject was used.Now, the patient has presented with a reaction.
Additional Manufacturer Narrative
The reported event could be confirmed based on the provided image of the patient.For additional information on the reported event it was reached out to the related sales representative.It was specified that the surgeon does not consider the reported event as an infection.He was not sure if he did something wrong or if the patient had some kind of reaction.Additionally the stryker senior global medical director was contacted to assess this complaint.He stated that based on the absence of any reports in literature, an allergic reaction to directinject is very unlikely.The device history record for the ¿directinject on demand ha cement¿ catalog # 79-45910, lot code # di17pq5 indicates (b)(4) nits were manufactured to specification and accepted into final stock on 2017-sep-11 with no reported discrepancies.Retain samples were brought back from storage facility, inspected and photographed by the investigation quality engineer at manufacturing location.The packaging integrity of the retain samples is intact.The obtained information was not sufficient to determine the complaint root cause.However, based on the investigation, the dhr review of the related manufacturing and quality documents, the check of the retain samples as well as based on the assessment of the stryker senior global medical director there is no indication for a design, material or manufacturing related issue.Therefore no corrective and/or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.The device was not returned for evaluation.
Event or Problem Description
It was reported that the patient underwent surgery in (b)(6) 2017 - direct inject was used.Now, the patient has presented with a reaction.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• MDR Report Key: 7985840
• Report Number: 0008010177-2018-00104
• Device Sequence Number: 1395817
• Product Code: GXP
• UDI-Device Identifier: 07613327123272
• UDI-Public: 07613327123272
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 79-45910
• Device Lot Number: DI17PQ5
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/19/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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