MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 3 LEFT MEDIAL; 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); Swelling (2091); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: 42538000401 - tibial component - 63755573; 42518200410 - articular surface - 63755573; 110034355 - refobacin bc r 1x40 us - 835aae2507.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03212, 0001822565-2020-03213.
Event or Problem Description
It was reported that the patient underwent an initial left unilateral knee arthroplasty.Subsequently, the patient experienced a fall three weeks post op.Approximately 2 months post implantation, the patient was revised due to difficulty ambulating, decrease in activity of daily living, pain, swelling, radiolucency, a periprosthetic fracture, loosening, subsidence, and poor bone quality.
Additional Manufacturer Narrative
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.
Event or Problem Description
Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 3 LEFT MEDIAL
• 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: 10524460
• Report Number: 3007963827-2020-00221
• Device Sequence Number: 14216788
• Product Code: HSX
• UDI-Device Identifier: 00880304808461
• UDI-Public: (01)00880304808461(17)290731(10)64465213
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/10/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42558000301
• Device Lot Number: 64465213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 90