MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DISTAL CENTRALIZER 9 MM O.D.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 00500104600 64840676 shell 46 mm o.D.; 00500104428 64785718 liner 28 mm i.D.For use with 44/45/46 mm o.D.Shells; 00801802802 64770377 femoral head sterile; 00785701200 64579834 femoral stem cemented; 00112112001 19da18180 hi-fatigue g bone cem 1x20 g (with gentamicin) x2.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0002648920 - 2021 - 00036, 0002648920 - 2021 - 00037, 0002648920 - 2021 - 00038, 0002648920 - 2021 - 00039.
Event or Problem Description
It was reported patient underwent a hip hemiarthroplasty for a subcapital hip fracture.During the procedure, the surgeon reports that the patient died from a pulmonary embolism not related to zb products.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that after implantation of a hip hemiarthroplasty (surgery due to a trauma related subcapital hip fracture) in an elderly female, the patient suffered a pulmonary embolism and died intraoperatively.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot or fat embolism breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism which can quickly turn fatal.As this is a procedure-related and patient condition related event, the device can be ruled out as causing or contributing to the event.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: h2; h3; h6.It was reported that after implantation of a hip hemiarthroplasty (surgery due to a trauma related subcapital hip fracture) in an elderly female, the patient suffered a pulmonary embolism and died intraoperatively.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.If a dvt/ blood clot or fat embolism breaks free, it may travel through the bloodstream and block blood flow to the lungs.This complication is called a pulmonary embolism which can quickly turn fatal.As this is a procedure-related and patient condition related event, the device can be ruled out as causing or contributing to the event.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.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: DISTAL CENTRALIZER 9 MM O.D.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11386102
• Report Number: 0001822565-2021-00530
• Device Sequence Number: 3767762
• Product Code: LPH
• UDI-Device Identifier: 00889024138667
• UDI-Public: (01)00889024138667(17)280131(10)63892327
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00785900900
• Device Lot Number: 63892327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 89 YR