MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE WITH HINGE POST SCREW SIZE F 12 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number 00588006012

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

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: femoral component option for cemented use only size f right: catalog#00588001602, lot#ni; unknown nexgen tibia size 5: catalog#ni, lot#ni; unknown cement: 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 a patient underwent an initial total knee arthroplasty.Approximately six years and ten months post implantation, the patient experienced a dislocation of the knee while getting up from a chair.Subsequently, the patient underwent revision surgery during which the surgeon noted that the screw fixing the hinge had backed out.The migrated screw and articular surface was exchanged without complication.The patella was also resurfaced and a patellar component was 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.The following sections have been updated: b4; b5; b7; d4; d6a; d10; g3; h2; h4; h10.D10: medical product: femoral component option for cemented use only size f right: catalog#00588001602, lot#11015334; tibial component precoat size 5: catalog#00588000500, lot#63032091; stem extension straight 16mm dia x 100mm length(combined length 145mm): catalog#00598801016, lot#62955353; stem extension straight 10mm dia x 100mm length(combined length 145mm): catalog#00598801010, lot#62937538; palacos r-40g cement: catalog#66017750, lot#81104418, qty#2.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right total knee arthroplasty.Approximately six years and four months post implantation, the patient experienced a dislocation of the knee while getting up from a chair.Subsequently, the patient underwent revision surgery during which the surgeon noted that the screw fixing the hinge had backed out.The migrated screw and articular surface were exchanged without complication.The patella was also resurfaced and a patellar component was implanted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h10.Visual examination of the returned products identified that the articular surface shows signs of being implanted (gouged, nicked, wear).The returned hinge post extension component showed signs of being implanted; damage to the threads and striations on the shaft.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: revision records: loosening/disassociation of the screw without trauma, no signs of implant loosening, no hinge fracture, no damage to poly identified, poly exchange and patellar resurfacing performed without complication.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.

Event Description

No further event information at time of this report.

• Brand Name: ARTICULAR SURFACE WITH HINGE POST SCREW SIZE F 12 MM HEIGHT
• 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: 13712763
• MDR Text Key: 286876099
• Report Number: 0001822565-2022-00645
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2022

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: 03/31/2020
• Device Catalogue Number: 00588006012
• Device Lot Number: 62996374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/17/2022; 06/17/2022
• Supplement Dates FDA Received: 03/23/2022; 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 85 KG