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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: segment with male/female taper 30 mm length catalog #: 00585004603 lot #:64953778; stem extension straight 12mm dia x 100mm length(combined length 145mm) catalog #: 00598801012 lot #: 767860; tibial component precoat size 2 catalog #:00588000200 lot #: 63814321; polyethylene insert xt size b use with distal femoral xt size b use with xt only catalog #:00585001296 lot #:64957759; fluted stem extension straight precoat 11 mm diameter 130 mm length for cemented use only catalog #: 00585205011 lot #:64953840; stem collar 35 mm o.D.For use with 16 mm or smaller diameter segmental stems catalog #: 00585204035 lot #: 65011891.Report source - foreign: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple reports were filed for this event, please see associated reports: 0001822565 - 2021 - 02220.

Event Description

It was reported that patient underwent a segmental knee procedure.Subsequently, a month later, patient underwent a revision procedure due to dislocation.Patient experienced pain and ambulation difficulties.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.The results of the investigation are as follows: -no product was returned or pictures provided; visual and dimensional evaluations could not be performed.-review of the device history record(s) identified no deviations or anomalies during manufacturing.-radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the left knee demonstrate surgical skin staples suggesting recent surgery.Osteopenia.Left total knee arthroplasty with posterior dislocation of the tibial component and loose screw noted posterior to the distal femoral component.-a definitive root cause cannot be determined.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 WITH SEGMENTAL HINGE POST SIZE B 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12359117
• MDR Text Key: 267852585
• Report Number: 0001822565-2021-02246
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 008889024195684
• UDI-Public: (01)008889024195684(17)290303(10)65013317
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• 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: 00585002012
• Device Lot Number: 65013317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR