MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 11 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 42502606202 - femoral component - 64432580; 42540200029 - patella - 64621836; 42532007102 - tibial component - 64459864; 110035368 - biomet bc r 1x40 us - 927eea2502; 110035368 - biomet bc r 1x40 us - 927eea2502.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains 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: 3007963827-2020-00197.
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Two days post op, the patient felt unsteady when walking and was experiencing pain.She fell twice in the same day, relatively close to each other in time sequence.The patient reported that she was not hurt in any way and did not have to receive any medical attention.In home physical therapy was ordered for one week daily.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The 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: patella was so large it looked like a second patella was attached to the native patella.Debrided in order to sublux effectively.Patella tracked centrally with no lift off or tilt.No complications noted during procedure.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: three views of the right knee demonstrate a right totally arthroplasty without fracture, dislocation, loosening or radiolucency.No significant joint effusion.Right total knee arthroplasty with expected appearance.Normal fit and alignment with osteopenia.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 or Problem Description
No further event information available at the time of this report.

• Brand Name: ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 11 MM
• 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: 10432235
• Report Number: 3007963827-2020-00198
• Device Sequence Number: 11450784
• Product Code: JWH
• UDI-Device Identifier: 00889024243040
• UDI-Public: (01)00889024243040(17)240930(10)64420396
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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 Expiration Date: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 42522200511
• Device Lot Number: 64420396
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 90