MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Udi :(b)(4).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.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty on an unknown date.Subsequently, the patient's tibial component due to loosening last month.
Event or Problem Description
It was reported that the patient underwent an initial knee arthroplasty approximately 18 months ago.Subsequently, the patient's tibial component was revised due to loosening.
Additional Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer.No devices or photos were received; therefore, the condition of the components is unknown.Device history record (dhr) was reviewed and no related discrepancies were found.X-ray review by mmi states anatomic alignment of the visualized portions of the right knee arthroplasty.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: TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE D
• 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: 11023173
• Report Number: 3007963827-2020-00328
• Device Sequence Number: 11425889
• Product Code: MBH
• UDI-Device Identifier: 00889024246683
• UDI-Public: (01)00889024246683
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

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: 42532006702
• Device Lot Number: 64235655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 01/25/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/05/2021; 01/26/2021
• 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