MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE LEFT 10 HOLES 223 MM LENGTH; PLATE, FIXATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Pain (1994); Loss of Range of Motion (2032); Swelling (2091)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was implanted with a distal femur plate to repair a fracture approximately four (4) months previous.Patient is now presenting with pain and swelling in left knee along with range of motion restrictions.Radiographs reveal that plate is fractured.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of the provided photographs and op notes.Of the explanted products that were provided.The plate fractured at the screw hole.Review of initial procedure op-notes noted the patient was presented with pain; swelling and painful rom with restrictions after a fall.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: DISTAL LATERAL FEMORAL PLATE LEFT 10 HOLES 223 MM LENGTH
• Type of Device: PLATE, FIXATION
• 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: 6903580
• MDR Text Key: 87745186
• Report Number: 0001822565-2017-06727
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK042598
• 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,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/20/2023
• Device Model Number: N/A
• Device Catalogue Number: 00235710210
• Device Lot Number: 62437855
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2013
• 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
• Treatment: UNKNOWN TRAUMA SCREWS (12)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR