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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00553 and 0001822565-2021-00554.Medical devices: unknown rhk femoral catalog#: unk lot#: unk.Unknown rhk femoral stem catalog#: unk lot#: unk.Unknown rhk tibial tray catalog#: unk lot#: unk.Unknown rhk tibial stem catalog#: unk lot#: unk.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 right knee revision due to disassociation of the locking pin.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, b5, g3, g7, h2.D6 implant date: unknown date in (b)(6) 2017.

Event Description

It was reported, that patient underwent a right knee revision, due to disassociation of the locking pin approximately (b)(6) years post implantation.The articular surface and hinge pin were revised.Attempts to obtain additional information have been made.However, no more is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of returned device, and medical records.Visual examination of the returned product identified signs of being implanted (gouged/nicked / wear).Hinge post extension exhibits signs of being implanted striations on the shaft/damage to the threads.Measured dimensions were within print specification.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: initial time point images demonstrate integrated hardware with slight lateral subluxation of the hinge hand with respect to the tibia.The later time point images taken demonstrate implant disassembly with the hinge can no longer within the joint space.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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

No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE W/ HINGE POST EXTENSION SCREW SIZE F 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11402727
• MDR Text Key: 234406708
• Report Number: 0001822565-2021-00553
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

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: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: 00588006012
• Device Lot Number: 62957462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 06/03/2021
• Supplement Dates FDA Received: 03/31/2021; 06/08/2021
• 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
• Patient Age: 61 YR
• Patient Weight: 115