MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in an initial procedure that when the surgeon placed the ceramic head over the muller steel taper, it immediately got skewed under a strange angle.It did clamp a bit, so impact was attempted twice without success.It was then noticed that flakes were coming off the head.Surgery was completed with another device without impact or consequence to the patient.Upon receipt of the ceramic head for evaluation, it was found to be fractured.No patient harm or further consequence was reported, however this event has led to serious injury in the past.Diligence is completed and no further information on the reported event is required.
Additional Manufacturer Narrative
(b)(4).D10.Unknown stem item# unk lot# unk avan uhmwpe insert 52/28 item# p0561052 lot# 0001758968.G2.Report source: netherlands.The biolox head was returned for investigation still assembled in the avantage bearing and the head chamfer is fractured into several pieces.On one side of the head taper, it is possible to see some marked longitudinal metal transfer; however, no consistent seating pattern all around the taper can be recognized.On the opposite side, on the inner chamfer, it is possible to see another metal transfer mark.This observation possibly indicates a suboptimal fitting of the stem in the head taper during impaction that might have contributed to the fracture.A review of the device manufacturing records of the head confirmed no abnormalities or deviations.Review of the complaint history of the head found no additional related complaints for this item and the reported part and lot combination.Based on the available information, a fracture of the biolox head can be confirmed and likely attributed to suboptimal connection between the stem and head at the moment of head impaction.However, with the available a definitive root cause could not be established.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.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 28/+3.5, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• 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: 19776946
• Report Number: 0009613350-2024-00303
• Device Sequence Number: 8115212
• Product Code: LZO
• UDI-Device Identifier: 00889024430303
• UDI-Public: (01)00889024430303(17)330829(10)3175439
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00877502803
• Device Lot Number: 3175439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• 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: 07/10/2024
• Initial Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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.
• Patient Sex: Unknown