MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHETIC, HIP

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).No product was returned, location unknown; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported the surgeon was preforming a cemented hemi hip arthroplasty for hip fracture.The surgeon reported he prepared the femoral canal with subsequent broaches to accept a size 4 cpt stem.The nurse prepared the cement, and the surgeon attempted to attach the size 4 cpt stem to the inserter.He noted difficult in treading the stem onto the inserter, and was not confident with the attachment.The surgeon introduced cement into the femoral canal and attempted to insert the stem.The stem would not completely seat, and the handle disassociated from the inserter.The surgeon attempted to use another instrument to insert the stem but was unable to completely seat the stem to the desired height.The surgeon removed the size 4 stem and removed the cement and re prepared the surgical canal for a secondary stem insertion.No further event information available at the time of this report.

• Brand Name: UNKNOWN STEM
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10949756
• MDR Text Key: 219876467
• Report Number: 0001822565-2020-04007
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other