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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER; PROSTHESIS, KNEE

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ZIMMER MANUFACTURING B.V. ALL-POLY PATELLA CEMENTED 35 MM DIAMETER; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Swelling (2091)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant associated products : item#:42522400711; articular surface fixed bearing posterior stabilized (ps); lot#:63749858.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.Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00220.
 
Event Description
It was reported the patient underwent right total knee arthroplasty approximately 3 years ago.The patient later experienced pain and swelling.The patient was thought to have a loose patellar component and was suspicious for infection.Upon revision on two months ago, the patellar component was not grossly loose, and signs of infection were not noted.Scar tissue was encountered and removed.The patella and liner were replaced.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Provided medical records were evaluated and the reported event was not confirmed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pre-operative diagnosis includes painful right knee replacement with previous history of infection, status post incision and drainage (see new complaint recommendation), possible patellar component loosening.Persistent swelling over last several months to a year and multiple aspirations were done all negative for growth (no infection).Abundant scar tissue with clear joint fluid, no obvious abscesses or other collections in the tissues that would be worrisome for infection patellar button was not grossly loose.Mild medial laxity corrected with slightly larger poly liner and slightly more constrained.Complete synovactomy performed to the anterior portion of the knee.Femoral and tibial components were evaluated with no signs of infection.Patella had abundant scar tissue around the perimeter.Small area of undermining for just a millimeter or two in the superior medial portion of the patella, but otherwise no gross loosening.Patellar button was removed since there was a question of previous infection.12mm cps poly liner placed with 38mm patella which provided better medial lateral stability with good flexion / extension and patellar tracking.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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.
 
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Brand Name
ALL-POLY PATELLA CEMENTED 35 MM DIAMETER
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key10522070
MDR Text Key206541781
Report Number0002648920-2020-00405
Device Sequence Number1
Product Code MBH
UDI-Device Identifier00889024247673
UDI-Public(01)00889024247673
Combination Product (y/n)N
PMA/PMN Number
K172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Model NumberN/A
Device Catalogue Number42540200035
Device Lot Number63604776
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/17/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received11/09/2020
Supplement Dates FDA Received11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight138
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