MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 ¿ biolox delta ceramic taper liner, size ff / 28 i.D.For use with 46 mm o.D.Size ff shell item# 00-8775-007-28, lot#2933863; allofit it alloclassic, shell for acetabulum, uncemented, 46/ff item#00-8755-046-00, lot#2930655.G2 ¿ foreign ¿ germany.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00489, 0009613350-2023-00490.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to dislocation, nine (9) months thirteen (13) days after initial hip arthroplasty.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
The biolox head, the biolox liner and the allofit cup were returned for investigation; of note, the liner and the cup are still assembled.The outer surface of the cup shows sign of bone onrowth.The flat rim of the cup shows some scratches.The liner shows some metal transfer on the articulating surface, on the edge between the flat rim and the articulating surface and on the flat rim itself.The head shows metal transfer on the articulating surface, especially on one side.The head taper shows circular and parallel metal transfers, typical seating patterns of the stem taper in the head.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.Review of the complaint histories identified additional similar complaints for the reported items and no additional similar complaints for the reported part and lot combinations.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Medical records were not provided.With the available information, a definitive root cause could not be determined.No corrective, preventive or field action was taken following the investigation of this event.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2023-00489, 0009613350-2023-00490.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: brexis short stem size 2 std item #0100651102 lot#20070875 investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 17601590
• Report Number: 0009613350-2023-00488
• Device Sequence Number: 6162268
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)320831(10)3123270
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-028-02
• Device Lot Number: 3123270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/04/2023; 11/17/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/02/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female