MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER UNI KNEE TIBILA COMPONENT PRECOAT LEFT MEDIAL RIGHT LATERAL SIZE 3; PROSTHESIS, KNEE

Catalog Number 00584200301

Device Problems Failure To Adhere Or Bond (1031); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 04/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: zimmer uni knee high flex precoat cemented component, item #: 00584201601, lot #: 63235401; zimmer uni articular surface size 3 , item #: 00584202309, lot #: 63217768.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that following a knee arthroplasty, the patient was revised due to tibial loosening.All components were revised.It was reported by the surgeon that the failure was not device related.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.Review of x-ray by radiologist indicates that left medial unicompartmental knee arthroplasty is present.The tibial component exhibits varus subsidence into the medial tibial plateau.The tibial component is small which is a risk factor for implant subsidence.Bones appear generally osteopenic, which is also a risk factor for implant subsidence.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported the patient was revised due to tibial subsidence.

• Brand Name: ZIMMER UNI KNEE TIBILA COMPONENT PRECOAT LEFT MEDIAL RIGHT LATERAL SIZE 3
• Type of Device: PROSTHESIS, KNEE
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6587075
• MDR Text Key: 75827929
• Report Number: 0001822565-2017-03517
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584200301
• Device Lot Number: 63270256
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention