MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ROTATING HINGE ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number 00588006014

Device Problems Detachment Of Device Component (1104); Disassembly (1168); Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032); No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2017

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.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 a patient was revised to address a damaged mechanism.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.It was reported that a patient was revised to address a damaged mechanism.A screw was noted to be disassembled and damage was noted to the femur and articular surface.No additional information is known at this time.Implant date - (b)(6) 2013.Explant date - (b)(6) 2017.Concomitant medical products - palacos cement catalog b6031993 lot 76054329, palacos cement catalog b6031993 lot 75554341, nexgen articular surface catalog 00588006014 lot 62157558, nexgen stem extension catalog 00598801014 lot 62389721, nexgen femur catalog 00588001601 lot 61958393, nexgen stem extension catalog 00598801015 lot 62339053, synplug size 16 reference 804022 lot 2008658.

Event Description

It was reported that a patient was revised to address a damaged mechanism.A screw was noted to be disassembled and damage was noted to the femur and articular surface.No additional information is known at this time.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.

Manufacturer Narrative

(b)(4).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 further reported that the patient had hinge dismantled pain, blockage, instability, and heard a noise.

Manufacturer Narrative

(b)(4).Reported event is considered confirmed as visual examination showed signs of that the hinge post and hinge post extension had fractured threads.The poly box insert was deformed and the femoral component had a foreign material on the surface.Fracture analysis of the hinge post revealed a suspected overload fracture.Device history record 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.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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: NEXGEN ROTATING HINGE ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6669186
• MDR Text Key: 78449721
• Report Number: 0001822565-2017-04433
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 00588006014
• Device Lot Number: 62157558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 100