MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: 00599600312 - lps all poly tib - 64253704.42540000035 - all poly patella - 64087383.Procedural related complications are influenced by the 'type of surgery, patients pre-existing comorbid state, and perioperative management.' low o2/oxygen levels in the blood stream is a known post-operative complication due to administration of anesthesia during the procedure.If the complication occurs, this should resolve within 24-48 hours¿ postoperative.Low o2/oxygen levels can also be impacted by the administration of narcotics during the post recovery phase.Narcotic side effects decrease patient¿s alertness and breathing rate, causing the patient to have shallow breathing impacting the amount of oxygen being supplied to the body.Multiple mdr reports were filed for this event, please see associated reports 0001822565-2020-01106.0002648920-2020-00206.
Event or Problem Description
It was reported that the patient underwent an initial total left knee arthroplasty.During the initial hospital stay, it was reported the patient experienced low oxygen saturation leading to prolonged hospitalization for treatment.The patient was sent home on oxygen therapy.

• Brand Name: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE D LEFT
• 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: 9880033
• Report Number: 3007963827-2020-00095
• Device Sequence Number: 14248955
• Product Code: JWH
• UDI-Device Identifier: 00889024001435
• UDI-Public: 00889024001435
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• 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
• Report Date (Section B): 03/25/2020

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: 00599601451
• Device Lot Number: 64160648
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/25/2020
• 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; Other
• Patient Weight: 57