MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 11 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling (2091)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi : (b)(4).Concomitant medical products: associated products : item#:42540200035; all-poly patella cemented 35 mm diameter; lot#:63604776.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: 0002648920 - 2020 - 00405.
Event or Problem 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 11 MM HEIGHT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 10522047
• Report Number: 3007963827-2020-00220
• Device Sequence Number: 19739022
• Product Code: MBH
• UDI-Device Identifier: 00889024243767
• UDI-Public: (01)00889024243767
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K121771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 42522400711
• Device Lot Number: 63749858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 138