MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 10; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	04/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: associated products : item#:00588606410; trabecular metalâ¿ ¢ posterior stabilized monoblock tibial component; lot#: 63703077.Item#:42540000038; all poly patella cemented 38 mm diameter; lot#:63950014.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.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: 0002648920-2020-00254, 3005751028-2020-00062.Device evaluated by manufacturer? still implanted.
Event or Problem Description
It has been reported bilateral total knee arthroplasties performed approximately two years ago.At the one year postop visit, the patient reported moderate pain, stiffness with sitting, and some instability in the right knee.No intervention or treatment has been given, and the patient remains satisfied.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Medical records were received, however the complaint cannot be confirmed.Primary operative notes provided states that no intraop complications were seen.Notes also state 2 year rom (right knee) 0-122°, patient not currently using any assistive devices for assistance with ambulation, patient complaints of recurrent right knee effusions.Office notes provided per crf report state that patient had pain, limited rom, instability and trouble in activity of daily living and difficulty ambulating.X-rays were provided but not sent for evaluation as complications such as stiffness an swelling would not be visible on xray and would be better evaluated on mri.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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: FEMUR CEMENTED CRUCIATE RETAINING (CR) STANDARD RIGHT SIZE 10
• 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: 10029373
• Report Number: 3007963827-2020-00138
• Device Sequence Number: 13619545
• Product Code: MBH
• UDI-Device Identifier: 00889024230422
• UDI-Public: (01)00889024230422
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42502606802
• Device Lot Number: 63932153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT#:00111214001 PALACOS LOT#: 88694748
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 135