MAUDE Adverse Event Report: BIOMET ORTHOPEDICS REDUCED SIZE OSS OSSADDITIONAL COMPONENTS- RS 8.5CM SEG FMRL RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Disassembly (1168); Device Dislodged or Dislocated (2923)

Patient Problem Muscle Weakness (1967)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Concomitant products ¿ oss rs 18mm tibial bearing catalog 161097 lot 913460; oss tibial yoke catalog 150493 lot 582320; oss poly tibial bushing catalog 150476 lot 889990; unknown oss tibial baseplate; oss poly lock pin catalog 150478 lot 710100; oss 21cm diaphyseal segment catalog 150473 lot 890180; oss rs poly femoral bushings catalog 161034 lot 746770; oss rs axle catalog 161035 lot 274510.Customer has not indicated that the product will 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.Multiple mdr reports were filed for this event, please see associated reports: 1825034-2017-03108, 1825034-2017-05298, 1825034-2017-05258, 1825034-2017-05259, 1825034-2017-05299, 1825034-2017-05300, 1825034-2017-05301, 1825034-2017-05302, 1825034-2017-05303.

Event Description

It was reported that the patient underwent a right knee revision approximately three months post implantation due to quadriceps deficiency.The patient was also reported as experiencing dislocation and disassociation.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.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the 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.

• Brand Name: REDUCED SIZE OSS OSSADDITIONAL COMPONENTS- RS 8.5CM SEG FMRL RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 6752949
• MDR Text Key: 81361290
• Report Number: 0001825034-2017-05303
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: PK051479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161123
• Device Lot Number: 965270
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention