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

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.

• 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 Key: 10522070
• MDR Text Key: 206541781
• Report Number: 0002648920-2020-00405
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024247673
• UDI-Public: (01)00889024247673
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• 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 Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 42540200035
• Device Lot Number: 63604776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 138