MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER HIGH FLEX PRECOAT FEMORAL COMPONENT; KNEE, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised for an unknown reason.Images of the device show the implant fractured.

Manufacturer Narrative

This report is being amended to reflect changes.This report will be amended when our investigation is complete.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Concomitant products - medical product - zimmer tibial plate, zimmer articular surface.This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.No devices were received; therefore the condition of the components is unknown.Photographs of the explanted devices show that the femoral component had fractured into two pieces.It can also be seen that the articular surface is severely worn.Review of the device history records for the femoral component identified an anomaly during the inspection after cleaning.During the sonic clean, the sonic button was not turned to 100%.All affected orders were rerun through the sonic cleaner.This anomaly did not cause or contribute to the reported event.This device is used for treatment.A complaint history search identified no other complaints for part 00-5842-014-02 related to implant fracture and no other complaints for lot 61095525.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Office visit notes from a consultation approximately one month before the revision identified an apparent transverse fracture of the femoral implant.Per the unicompartmental knees package insert, fracture/damage of the prosthetic knee components or surrounding tissues is a known risk of this procedure.A definitive root cause cannot be determined with the information provided.

Manufacturer Narrative

Concomitant medical product: item number: 00584202314, item name: articular surface size 3 14 mm, lot: 60905180.Item number: 00584200302, item name: tibial component precoat size 3, lot: 60886338.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: the complaint is confirmed as product was returned.The femoral component was returned fractured between the two pegs; attached foreign material was noted.Fracture analysis was performed and shows: the visible artifacts on the fracture surface suggest a fatigue fracture may have initiated approximately 2mm inboard of the corner.A possible lack of bone cement support in the central section likely contributed to that area to be unsupported, possibly contributing to the stress that caused the fatigue fracture.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Per the unicompartmental knees package insert, fracture/damage of the prosthetic knee components or surrounding tissues is a known risk of this procedure.A definitive root cause cannot be determined with the information provided.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 that patient was revised approximately two months later due to pain and fracture of the femoral component.During the revision, an intraosseous cyst was removed and bone defects were corrected.No further event information available at the time of this report.

Manufacturer Narrative

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 further reported by patient's legal counsel that the patient's ct examination of the osteoarticular system showed a transverse fracture within the femoral prosthesis, in the middle part of the articular surface.The fracture resulted in an unknown series of medical actions and a revision procedure.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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

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

• Brand Name: ZIMMER HIGH FLEX PRECOAT FEMORAL COMPONENT
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5633447
• MDR Text Key: 44459035
• Report Number: 0001822565-2016-01433
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK033363
• 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,Followup,Followup,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00584201402
• Device Lot Number: 61095525
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2008
• 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; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 84