MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STANDARD FEMORAL STEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 02/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item number: unknown, item name: unknown stem inserter, lot #: unknown item number: 00223200228, item name: cerclage cable with crimp, lot #: 63820962, item number: 00223200228, item name: cerclage cable with crimp, lot #: 63775363, item number: 00223200228, item name: cerclage cable with crimp, lot #: 63820962, item number: 00223200228, item name: cerclage cable with crimp, lot #: 63827903, item number: 00223200228, item name: cerclage cable with crimp, lot #: 63820962, item number: 00223200301, item name: bone plate, lot #: 61219708, item number: 00223200318, item name: cable for bone plate, lot #: 63377420, item number: 00223200318, item name: cable for bone plate, lot #: 62235733, item number: x170311, item name: integral femoral stem, lot #: 469440, item number: 163662, item name: femoral head, lot #: 007270, item number: 11-165220, item name: ringloc bi-polar cup, lot #: 062900.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01705.

Event Description

It was reported that during a total hip arthroplasty the stem would not assemble with the stem inserter.Multiple screws were attempted to be used to assemble the devices; however, they failed to attach.The surgeon attempted to insert the stem in to the femoral canal without being assembled to the inserter, but the cement had already begun hardening and the stem was stuck halfway down the canal.The procedure was completed with a different stem.Surgery was delayed approximately 6 hours.Attempts have been made and no further information is available.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The femoral stem was returned and evaluated against the complaint.Foreign debris and scuffing of the porous coating was found on the distal end of the stem.An unknown hex screw is assembled with the threads of the stem.Corrosion was observed around the screw inside the stem.No attempt was made to remove the hex screw.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was determined to be related to the manufacturing process.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.Udi #: (b)(4).

Event Description

No further event information available at the time of this report.

• Brand Name: STANDARD FEMORAL STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7332665
• MDR Text Key: 102182123
• Report Number: 0001825034-2018-01704
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: PK942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 12-162613
• Device Lot Number: 770520
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR