MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ACM KIT W/ FEMORAL BREAKAWAY NOZZLE & PROX. MED. PRESS.; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0306573000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : not available.
Event or Problem Description
The reported event occurred during a right hemi hip procedure with a cemented stem.The cement was mixed and the acm delivery system was used to begin injection of the cement into the medullary canal.During cement injection, the nozzle of the acm came off.The surgeon re-attached the nozzle of the acm, which took 1-2 minutes.The surgeon was able to inject the remaining viable cement in the acm and continued with the procedure.It was reported there were challenges when placing the size 5 stem, as it was sitting 2cm proud.The surgical procedure required modification and became more complex when the surgeon removed the implant and used a curette to retrieve cement from the canal.All cement that had been injected could not be removed.A size 2 implant was placed, which sat 1cm proud.The size 2 stem was then removed.These steps of the surgical procedure occurred over approximately 60 minutes, at which point the procedure was concluded without a stem being implanted.It was reported the patient had developed an unspecified cardiac issue and later expired.This report is for the malfunction of the acm nozzle detaching during use, and the associated medical intervention.Mfr report # 0002249697-2023-00570 was submitted to report the information regarding the associated cement and patient death.

• Brand Name: ACM KIT W/ FEMORAL BREAKAWAY NOZZLE & PROX. MED. PRESS.
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17050312
• Report Number: 3015967359-2023-01227
• Device Sequence Number: 7039634
• Product Code: JDZ
• UDI-Device Identifier: 34546540055416
• UDI-Public: 34546540055416
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/02/2023

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 Catalogue Number: 0306573000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/02/2023
• 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: Female