MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10.28mm i.D.46mm o.D.Size g bearing item# (b)(4) lot#65994698.
Event or Problem Description
It was reported in hip replacement that the head do not assembly as intended within the bearing displayed significant play.There was no surgical delay or complications.Foreign body was not retained.Another head was used to complete the surgery.Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Visual review of the returned ceramic head confirms head was seated in the liner upon return with no damage.The head exhibited audible clunks and "play" felt within the liner when moved in all directions.During evaluation further investigation of the head was needed.Ceramic head was removed from the liner for dimensional analysis.Dimensional analysis was done on the overall height and overall spherical diameter.Both dimensions were in specification.Liner was returned as associated product.Therefore, it is determined that the product meets the applicable acceptance criteria and is conforming to the specifications.Additionally, one image of the reported product assembled with the liner was provided.The product is shown in the operating theater and covered in some biological debris.Nothing inconspicuous can be identified.A review of the risk management file has not been completed as the product is considered unrelated to the reported event.Complaints are monitored per complaint trending process.Based on the available information, the reported event can be confirmed.However, no product issue could be identified with the reported biolox ceramic femoral head.The root cause of the reported issue is therefore unrelated to the zimmer biomet medical device.Upon reassessment of the case it was found that there was no harm or injury to a patient nor is the same malfunction likely to cause or contribute to a serious injury.This report was forwarded in error and should be considered void.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 28/0, 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: 19944024
• Report Number: 0009613350-2024-00340
• Device Sequence Number: 11984547
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)330824(10)3168183
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/03/2024

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: 00877502802
• Device Lot Number: 3168183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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 Age: 62 YR
• Patient Sex: Male