MAUDE Adverse Event Report: ZIMMER, INC. ZUK UNIVERAL HIGH FLEX PRECOAT FEMORAL COMPONENT RIGHT MEDIAL/LEFT LATERAL; PROSTHESIS, KNEE

Catalog Number 00584201402

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Reference (b)(4).Medical products- zimmer precoat tibial component right medial/left lateral size 3, item # 00584200302, lot # 63263888.Zimmer articular surface size 3, item # 00584202308, lot # 63211888.Foreign source- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to device being discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported following a knee arthroplasty, the patient was revised due to pain.During the revision, it was noted that the femoral component was loose, and oversized.The femoral component implanted was downsized.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Manufacturer Narrative

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.

• Brand Name: ZUK UNIVERAL HIGH FLEX PRECOAT FEMORAL COMPONENT RIGHT MEDIAL/LEFT LATERAL
• 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: 6659790
• MDR Text Key: 78154376
• Report Number: 0001822565-2017-04356
• 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,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00584201402
• Device Lot Number: 63218907
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR