MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Foreign: china.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the agent disassembled the ceramic head and assembled it into the bipolar head in the correct way.After the doctor implanted the product, he found that the femoral head could not be fixed on stem stably and formed a taper locking.There was a 70 minute delay in the surgery.Prolonged anesthesia time and increased blood transfusion.
Additional Manufacturer Narrative
Supplemental report provided as an update was provided to the complaint description (b5) that was previously reported under mfr#: 0001822565-2022-03446.
Event or Problem Description
It was reported that the doctor assembled the ceramic head into the bipolar head in the correct way.After the doctor implanted the product, he found that the femoral head and the shank cone could not form a taper lock and the fixation was unstable.There was a 70-minutes delay in this surgery with prolonged anesthesia time and increased blood transfusion.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: d6b: device remains implanted.H6: proposed component code: mechanical (g04)-stem.Visual examination of the provided videos in the linked complaint identified the head was loose on the stem taper.No further evaluation can be made from the provided videos.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined for the head and stem not locking together.The increased blood transfusion/blood loss was determined to be procedure related after review by a hcp.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
There is no update to the previous complaint description provided.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER
• Common Device Name: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15961921
• Report Number: 0001822565-2022-03446
• Device Sequence Number: 14869978
• Product Code: LZO
• UDI-Device Identifier: 00889024131750
• UDI-Public: (01)00889024131750(17)320515(10)65353315
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

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: 00771100910
• Device Lot Number: 65353315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 01/18/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/04/2023; 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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
• 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: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male