MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Separation Problem (4043)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 0106010201, avenirâ®, stem, standard, cemented, 1, taper 12/14, taper 12/14, lot#: 3173117.Item#: unknown, unknown cup/liner, lot#: unknown.G2: report source germany.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 patient underwent hip revision approximately 21 days post implantation due to a dislocation caused by a fall in the domestic environment.During the intraoperative attempt to detach the head from the stem, the head and stem came out of the medullary cavity of the femur after the third stroke.As a result, the medullary canal had to be partially freed from the cement in order to be able to place a new stem including a new thin cement mantle and a head with more offset had to be implanted.Delay 60 minutes for complex partial removal of the cement in the femur to make room for re-implantation and partial new cement mantle, trial reduction, re-implantation including hardening of the cement, reduction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.D10: item # 0106010201, avenirâ®, stem, standard, cemented, 1, taper 12/14, taper 12/14, lot # 3173117.Item # unknown, unknown cup/liner, lot # unknown.Item # unknown, unknown cement, lot # unknown.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.The reported products were reviewed for compatibility with no issues noted.Due to insufficient product information on the liner, the compatibility of the involved products could not be verified.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored in order to identify potential adverse trends.Medical records were not provided.Based on the available information, the reported event cannot be confirmed.The contributing factors that lead to the intraoperative issue are multiple: either the head and the stem could not be disengage from each other, leading to the loosening of the stem from the cement mantle at the moment of the impaction on the head; or the mantle and the stem were already loose, therefore the stem came out even with minimal impaction on the head.With the available information neither the root cause of the dislocation, neither the root cause for the intraoperative can be definitively determined.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
No further event information available at the time of this report.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 32/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20613855
• Report Number: 0009613350-2024-00521
• Device Sequence Number: 20696343
• Product Code: LZO
• UDI-Device Identifier: 00889024430327
• UDI-Public: (01)00889024430327(17)340613(10)3197158
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 02/20/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00877503202
• Device Lot Number: 3197158
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female