MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT; KNEE PROSTHESIS

Catalog Number 00584200201

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.Returned, not yet evaluated.

Event Description

It is reported that the patient underwent knee arthroplasty revision due to loosening of the tibial component.

Manufacturer Narrative

Concomitant products: zimmer uni articular surface catalog #: 00-5842-022-10 lot #: 60476367, zimmer uni femoral component catalog #: 00-5842-012-01 lot #: 60756176.This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This is report 1 of 2 for this patient.See also 0001822565-2017-00149.The tibial component was not returned for evaluation.Inspection of the articular surface identified wear and gouges along the edges.Wear and scratches were also noted on the contact point of the femoral component on the condylar surface.The damage to the articular surface prevented accurate dimensional analysis.Review of the device history records for the tibial component and articular surface identified no deviations or anomalies.This device is used for treatment.A complaint history search identified no other complaints for this lot.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Review of the immediate post-op x-rays from the primary surgery identified the components exhibited typical fit and alignment.Review of the x-rays identified that decreased medial femorotibial space could be seen over time, which indicates wear of the articular surface.Medial subluxation of the tibia was also noted.Review of x-rays from approximately four years after the primary surgery confirmed the lucency subjacent to the posterior tibial plate and a vertical split fracture of the medial tibial plateau.The implanted devices were reviewed for compatibility with no issues noted.Per the unicompartmental knees package insert, loosening or fracture/damage of the prosthetic knee components or surrounding tissues are known risks of this procedure.Per the surgical technique, when evaluating the patient and planning for the procedure, the surgeon should consider tka if the patient¿s acl is deficient.Review of the pre-op mri image confirmed that the patient did not have a functional acl at the time of the primary surgery.It appears that patient¿s dysfunctional acl did not provide adequate stability for the knee and appropriate kinematics, which led to wear of the articular surface and subsequent loosening of the tibial component.The root cause is considered to be related to patient factors.

• Brand Name: ZIMMER UNICOMPARTMENTAL KNEE PRECOAT TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5933361
• MDR Text Key: 54096990
• Report Number: 0001822565-2016-02900
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Catalogue Number: 00584200201
• Device Lot Number: 61790561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2011
• 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: 83 YR