MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5; BIOLOX CERAMIC FEMORAL HEAD PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells item # 00630505036, lot #63613766.Shell porous with cluster holes 54 mm o.D.With calcicoat ceramic coating item # 65620005422, lot #63454224.Femoral stem 12/14 neck taper ext.Offset size 1 130 mm stem length item # 00811400110, lot #63701554.Bone screw self-tapping 6.5 mm dia.30 mm length item # 00625006530, lot #63696911.Femoral pressurizer seal small natural item # 32833401002, lot #63667127.Allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter core store in cool dry place item # 00801102020, lot #63777096.G2: foreign: australia.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had a revision surgery due to dislocation, approximately six years after implantation.The liner and head were revised.Due diligence has been completed for this complaint; to date all available additional information has been received.
Event or Problem Description
No additional event information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.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 per complaint trending process in order to identify potential adverse trends.Based on the available information the reported event can be confirmed.A definitive root cause could not be determined.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: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5
• Common Device Name: BIOLOX CERAMIC FEMORAL HEAD PROSTHESIS
• 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: 20085526
• Report Number: 0009613350-2024-00409
• Device Sequence Number: 18056136
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: (01)00889024430372(17)270430(10)2897044
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/27/2024

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: 00877503603
• Device Lot Number: 2897044
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female