MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW; PROSTHESIS, KNEE

Catalog Number 00588005014

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown femoral component: catalog#ni, lot#ni.Report source: foreign: (b)(6).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 patient underwent a revision knee arthroplasty.Six years post implantation the articular surface dislocated, requiring a second revision surgery.The poly was exchanged without incident.Attempts have been made and no further information has been provided.

Event Description

It was reported that patient underwent a revision knee arthroplasty.Six years post implantation the articular surface dislocated, requiring a second revision surgery.The pin had become unscrewed in the knee.Surgeon screwed in a new pin and exchanged the poly without incident.All other components remain implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: medical product: fem size e, right: catalog#00588001502, lot#62867390.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of extreme wear (nicked, gouged, micro motion), the thread on the hinge post extension has fractured.Device was submitted for further analysis.Analysis determined the hinge post thread fractured due to shear overload.Excessive smearing observed near the suspected crack initiation edge on the hinge post thread fracture surface.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: there is disassociation of the right knee arthroplasty with the hinge screw displaced and interposed between the femoral and tibial components.The polyethylene implant appears to be anteriorly displaced.No fracture is identified.Implant fit and alignment is maintained.No implant loosening, abnormal radiolucency or other abnormality.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST EXTENSION SCREW
• 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: 12673330
• MDR Text Key: 277668189
• Report Number: 0001822565-2021-03074
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013385
• 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
• Report Date: 02/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 00588005014
• Device Lot Number: 62865937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 02/24/2022
• Supplement Dates FDA Received: 11/09/2021; 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• 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 Sex: Prefer Not To Disclose
• Patient Weight: 108 KG