MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH; PLATE, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source - foreign: event occurred in (b)(6).Concomitant medical products: item# 00235904645; 4.5 mm locking screw 46 mm length; lot# 61840881.Item# 00235903645; 4.5 mm locking screw 36 mm length; lot# 63228628.Item# 00235903445; 4.5mm locking screw 34mm lng; lot# 63975378; (qty.2).Item# 00234702336; cortical bone screw selftapping hex head 4.5 mm diameter 36 mm length; lot# 63952168.Item# 00235906555; 5.5 mm cannulated locking screw 65 mm length; lot# 62493182.Item# 00235906555; 5.5 mm cannulated locking screw 65 mm length; lot# 62874291; (qty.2).Item# 00235906055; 5.5 mm cannulated locking screw 60 mm length; lot# 63163985; (qty.2).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent zplp distal femoral internal fixation surgery.Subsequently, the patient started experiencing in his right leg while climbing stairs, and the pain did not decrease after a short rest.The patient was revised due to fracture of the right lateral femoral plate.Attempts have been made and additional information on the reported event is unavailable at this time.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures, op-notes and x-rays which stated right femoral fracture, internal fixation, plate fracture.2 days prior using stairs sudden right thigh pain, unable to bear weight without relief with rest.Dx right femoral lateral steel plate fracture.Visual examination of the provided pictures identified the item fracture.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: DISTAL LATERAL FEMORAL PLATE RIGHT 14 HOLES 286 MM LENGTH
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10401211
• Report Number: 0001822565-2020-02705
• Device Sequence Number: 19630889
• Product Code: HRS
• UDI-Device Identifier: 00889024055964
• UDI-Public: (01)00889024055964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00235710114
• Device Lot Number: 63612082
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR