MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHESIS, HIP

Catalog Number	00877503602
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # 010000935, g7 hi-wall e1 liner 36mm e, lot # 6744975, item # 30.00.49-080, stem ms-30 8 polished, lot # 3030382, item # 01.00358.010, distal centralizer 8/10 ms-30, lot # 3038070, item # 00801102020, allen medullary cement plugs 1-20 mm diameter flange/10 mm diameter, core store in cool dry place, lot # 64573394, item # 010000703, g7 bonemaster ltd acet shl 52e, lot # 6744975.G2: report source 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 supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported patient underwent hip revision approximately 4 years and 3 months post implantation due to dislocation.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that the patient underwent a primary hip arthroplasty.Subsequently, the patient was revised four (4) years and three (3) months post implantation due reoccurring dislocations.The cup positioning was poor.Liner and cup were explanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).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.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.No product was returned for evaluation.However, two pictures were received.In one picture, the shell can be seen (linked complaint (b)(4)), and in the other picture, the revised liner (linked complaint (b)(4)) and ceramic head are visible.Given the biological tissue on the products, it can be assumed that the pictures were taken right after the revision surgery.The ceramic head is covered in blood and therefore no further assessment can be made.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.Based on the available information, the reported event cannot be confirmed the information received through correspondence indicate that the cup positioning was poor.However, with the available information, 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, 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: 21421586
• Report Number: 0009613350-2025-00079
• Device Sequence Number: 7913288
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)300228(10)3020310
• 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: 2020
• Device Explanted Year: 2025
• 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): 04/10/2025

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 Catalogue Number: 00877503602
• Device Lot Number: 3020310
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 03/21/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/17/2025; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 96 KG