MAUDE Adverse Event Report: BIOMET ORTHOPEDICS STAGE ONE SELECT HIP SPACER STEM MOLD WITH REINFORCEMENT; HIP PROSTHESIS

Model Number N/A

Device Problems Fracture (1260); Device Difficult to Setup or Prepare (1487)

Patient Problem No Code Available (3191)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.

Event Description

It was reported that the cement mixture would not advance from the cement delivery device into the spacer mold.During attempts to push it through, the mold fractured above the filling connector.Another device was available to complete the procedure; however, the event resulted in a delay of one hour.

Manufacturer Narrative

This follow up report is being submitted to report additional information complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the hip mold stem was fractured just above the bone cement connector port.The bone cement fill tube was deformed and could not provide any further dimensional analysis.Evidence of bone cement hardened inside and is oozing out of connection port.Plug was not returned with the parts.The silicone mold is approximately half-filled with cement around the reinforcement stem.All measured features were found to be conforming to specifications.The ftir spectrum of the material was found to be conforming to specifications.Sem analysis was conducted, and found: the viscosity/flow of the cement at the time of mold filling is unknown.It is also unknown if the mold burst from the pressurized cement alone, or if during the mold filling , the unsupported mold was torqued and tore from the cement gun/cartridge assembly, or a combination of both may have contributed to the mold failure.Complaint history review determined that no further action(s) is/are required.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not 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.

• Brand Name: STAGE ONE SELECT HIP SPACER STEM MOLD WITH REINFORCEMENT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6310203
• MDR Text Key: 66763117
• Report Number: 0001825034-2017-00318
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 431195
• Device Lot Number: 160680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2014
• 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): Hospitalization; Other
• Patient Age: 80 YR