MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Abdominal Pain (1685); Cardiac Arrest (1762); Death (1802); Nausea (1970); Thrombosis (2100); Vomiting (2144); Thrombosis/Thrombus (4440)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(udi): n/a.Concomitant medical products: catalog #: 42530006401, natural tibia trabecular metal two-peg, lot # 77007007; catalog #: 42512100412, articular surface medial congruent, lot # 63998720; catalog #: 42540000032, all poly patella cemented, lot # 64208861.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient has died.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-01574, 3007963827-2019-00107, 0002648920-2019-00273.Remains implanted.
Event or Problem Description
It was reported that the patient underwent an initial left knee on approximately four months ago.The patient died on postop day three due to unknown reason.
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was further reported that the patient experienced abdominal pain, bloating, nausea, shortness of breath, and vomiting post-operatively day two and morning of day three.Subsequently, the patient expired on post-operative day three due to procedural related complications including deep vein thrombosis (dvt) and possible pulmonary embolism (pe).However, this was unable to be tested due to the patient condition.It was also noted that there were occlusive and non-occlusive thrombus located in the femoral vein as well as non-occlusive thrombus located in other areas.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Reported event was considered confirmed as patient had died.X-rays showed normal appearance of left tka.Device history record was reviewed and no discrepancies relevant to the reported event were found.Reported issues are related to the procedure and are not abnormal to the procedure.No failure detected with the devices.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.
Event or Problem Description
It was reported that the patient underwent an initial left knee arthroplasty.The patient experienced abdominal pain, bloating, nausea, shortness of breath, and vomiting post-operatively day two and morning of day three.Subsequently, three days post-operative, the patient experienced a cardiovascular related death.There were procedural related complications including deep vein thrombosis (dvt) and possible pulmonary embolism (pe).However, this was unable to be tested due to the patient condition.It was also noted that there were occlusive and non-occlusive thrombus located in the femoral vein as well as non-occlusive thrombus located in other areas.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been corrected/updated: b4; b5; d4; e1; g1; g3; h2; h6; h10; h11.Additional information has prompted a review of the previously reported investigation results.The investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h6; h11.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records was not performed.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Side effects of the administration of anesthesia are a known cause of chest pain, ekg changes, and myocardial infarction (heart attack) during the intraoperative and postoperative recovery.Elective total joint patients typically have a cardiac workup prior to surgery to assess the patient¿s physical readiness for surgery, hence reducing their risk for these cardiac related complications.Patients are at the highest risk immediately post op.As the reported complaint indicated, a cardiac arrest occurred on pod3 resulting in a cardiovascular death.As there are multiple factors that may contribute to cardiovascular death that are outside the control of zimmer biomet, the root cause of the reported event was determined to be non-device related factors.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.

• Brand Name: FEMUR CEMENTED CRUCIATE RETAINING (CR) NARROW LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 8523535
• Report Number: 3007963827-2019-00106
• Device Sequence Number: 19550480
• Product Code: JWH
• UDI-Device Identifier: 00889024229891
• UDI-Public: (01)00889024229891(17)281031(10)64196777
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/21/2025

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: 42502006001
• Device Lot Number: 64196777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 12/09/2019; 06/27/2025; 10/27/2025
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/09/2019; 12/20/2019; 07/25/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White