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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 the patient was revised to address a fractured implant.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Concomitant devices ¿ zimmer unicompartmental articular surface size 5 8mm catalog #: 00584202508 lot #: 61984371, zimmer unicompartmental precoat tibial component size 5 catalog #: 00584200502 lot #: 61795467 the complaint sample was evaluated and the reported event was confirmed.The returned femoral component showed signs of use (nicked, gouged, scratches) as well as fracture.The device also had residual bone cement attached to the back side.Scanning electron microscopy (sem) analysis identified that the femoral component was fractured into two pieces.The fracture suggests that there may have been a possible lack of bone cement support in the central section that could have contributed to the area to be unsupported, possibly contributing to the stress that likely caused the fatigue fractures.The device history records were reviewed and no discrepancies relevant to the reported event were identified.Radiographic inspection of initial images confirmed an overall fit and alignment of the implants with no indications of potential complication.However, images prior to the revision confirmed that the anterior portion of the medial compartment of the femoral component was fractured with a fractured hardware fragment noted within the medial compartment.Degenerative changes of the lateral compartment were also seen.Per package insert, implant fracture is one of the adverse effects of the tka procedure.However, 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.

• Brand Name: ZIMMER HIGH FLEX FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• 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: 7302324
• MDR Text Key: 101130263
• Report Number: 0001822565-2018-00809
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00584201602
• Device Lot Number: 61252840
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2009
• 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: 79 YR
• Patient Weight: 75