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

Model Number	79-45910
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was clear fluid accumulation after use of directinject bone cement.A revision surgery was conducted.No further information is known at this time.
Additional Manufacturer Narrative
Device not returned for evaluation as it was discarded by the hospital.If additional information is received it will be reported on a supplemental report.This covers complaints regarding lot# d120125, lot# 121005, and lot# d120pq2.

• Brand Name: DIRECTINJECT ON DEMAND HA CEMENT
• Common Device Name: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: amelia kesti ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 76145120
• MDR Report Key: 12867775
• Report Number: 0008010177-2021-00048
• Device Sequence Number: 19725803
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 79-45910
• Device Catalogue Number: 79-45910
• Device Lot Number: DI20125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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