MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CUSTOM TITANIUM OSS RS MAK 7CM SEGMENTAL FEMORAL ROTATING HINGE KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unknown if product will be returning to zimmer biomet and 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.Oss 3cm ellip diaphyseal seg, catalog# 150461, lot # 859110.

Event Description

It was reported that the patient may require a revision procedure due to extra external rotation is needed for appropriate kinematics.No revision has been reported to date.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of device history records found these units were released to distribution with no deviations or anomalies.No device or photos were received; therefore the condition of the component is unknown.The custom device on this complaint is specifically designed to be compatible with its mating standard-line and custom devices.No medical records received.Root cause could not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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

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

• Brand Name: CUSTOM TITANIUM OSS RS MAK 7CM SEGMENTAL FEMORAL ROTATING HINGE KNEE
• 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: 7562465
• MDR Text Key: 109836837
• Report Number: 0001825034-2018-03708
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PCUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: CP116574
• Device Lot Number: 073840
• Other Device ID Number: (01) 0 0880304 85770 4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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: CUS TI 63AVL 160X10TIB POR10AG; CUS TI OSS AVL YOKE KIT; CUS TI OSS RS LOCK AXLE KIT; MAK OSS BUMPER PLUS; MAK OSS SIDE LOCK STEM SCREW; OSS 3CM ELLIP DIAPHYSEAL SEG; OSS CEMENTED IM STEM 14X150; OSS TIB POLY BEARING 16
• Patient Outcome(s): Hospitalization; Required Intervention