MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): d10: item # 00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot # 62757083.Item # 00-6202-054-22, tm acet shell 54mm cluster, lot # 63365704.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 right hip revision approximately 7 years 8 months post implantation due to the patient's hip squeaking, caused by wear in the liner and possible placement problems, which therefore damaged the cup and head.Attempts have been made and additional information on the reported event is unavailable at this time.
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.Corrected: h4.No product was returned.Visual examination of the provided pictures show the retrievals after revision.The revised devices are in a bloody condition, therefore a detailed statement cannot be done.The ceramic head is visible only in one picture.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Radiographs were provided.The provided x-ray picture is undated and therefore it is difficult to make a statement on this.However, the stem, head and shell can be seen on the picture.With the available information, a definitive root cause cannot be established.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, S, ø 36/-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: 20409167
• Report Number: 0009613350-2024-00485
• Device Sequence Number: 7983766
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: (01)00889024430358(17)250630(10)2798737
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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 Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 00877503601
• Device Lot Number: 2798737
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2015
• 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: PLEASE SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male