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

Catalog Number 00584200102

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 04/10/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the patient was revised due to loosening.

Manufacturer Narrative

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

Manufacturer Narrative

A visual review of the returned devices was performed.All three parts exhibited marks and defects cause by the removal process.The femoral component retained the cement mantle as well as bone attached to the cement.The femoral condyle showed evidence of scratches due to removal as well as scratches due to third body wear.Third body wear is likely bone or cement debris getting caught between the femoral and articular surface.The tibial plate retained most of the cement with minimal bone attached.Damage from removal of the articular surface can be seen on the proximal surface of the tibial plate.The articular surface exhibits wear and pitting on the proximal side that contacts the femoral implant.The pitting seen is likely 3rd body wear from bone debris or loose bone cement.The wear seen is located medially on the surface.Gouges can be seen on the anterior and posterior edges of the device, likely due to removal.The device history records for the implants were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.These devices are used for treatment.Compatibility of the implanted devices was checked using the zimmer unicompartmental product profiler with no issues found.Surgical notes of the primary or revision surgery were not provided.X-rays post primary and revision surgeries were provided.The x-rays of the primary surgery show that the femoral implant was medially loaded over the tibial implant.The location of the wear seen is likely due to this positioning.The revising surgeon has noted, ¿i assume that insufficient posterior inclination of the tibial base plate at the primary surgery might have caused a regional stress to the poly surface.¿ as the wear is localized on the articular surface, the wear seen over the life of the implant is considered normal.The wear seen is consistent with natural compression and wear of the device over its 10 year life.The pitting seen from the wear debris appears to be in the initial stages and had not adversely affected the thickness of the articular surface.Loosening of the implants was initially expected however the surgeon confirmed there was no loosening evident at the time of revision surgery.The patient was also experiencing a progression of osteoporosis.The patient had increased osteoarthritis on the lateral side of the right knee, therefore a full tka was performed and the zuk implants were removed.The likely root cause is noted per the surgeon¿s comments that the revision surgery was due to the continued osteoarthritis the patient was experiencing.

Event Description

It has been further reported that the patient's conversion to a total knee from a unicompartmental knee was due to advancing osteoarthritis.

• 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: 5717072
• MDR Text Key: 47115802
• Report Number: 0001822565-2016-01984
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 00584200102
• Device Lot Number: 60424921
• 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: 09/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2006
• 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