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	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a primary hip surgery the ceramic head was chipped fractured/chipped during impaction.There was no impact to patient and the surgery was completed with another head.Diligence is completed and additional information is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10.G7 dual mobility liner 42mm e item# 110024463 lot# 66468245.G7 osseoti 3 hole shell 52mm e item# 110010244 lot# 66283179.Avenir cmpl ha ho nc size 4 item# 574102040 lot# 3176270.Vivacit-e dm bearing 28x42mm item# 110031011 lot# 66326537 biolox delta fem head, 28mm, +0mm item# 00-8775-028-02 lot# 3170540 28mm i.D.42mm o.D.Size e bearing item# 110031011 lot# 66326537 28mm i.D.42mm o.D.Size e bearing item# 110031011 lot# 66433257 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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.The reported product was returned assembled with the dual mobility bearing to the product surveillance team for examination.The reported issue can be confirmed.A portion of the ceramic femoral head has fractured off.The fractured off fragment was however not returned.Two impaction marks on the rim of the ceramic femoral head with a potential third at the fractured site can be identified at roughly 120° from each other.There are no typically observed seating marks/metallic smearing to be seen within the taper of the ceramic femoral head.Nothing conspicuous can be seen when observing the dual mobility bearing.The ceramic femoral head moves freely within the polyethylene bearing.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the available information, the reported event can be confirmed.Based on the returned product it can be assumed that the ceramic femoral head was not fully or properly seated on the trunnion of the stem prior or during impaction.If and to what extend other possible contributing factors may have played a role in the reported event remain unknown.As a result, 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.
Event or Problem Description
Diligence is completed and additional information is unavailable at this time.

• 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: 19088892
• Report Number: 0009613350-2024-00134
• Device Sequence Number: 18097622
• Product Code: LZO
• UDI-Device Identifier: 00889024430297
• UDI-Public: (01)00889024430297(17)330918(10)3175527
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200112
• 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): 08/30/2024

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: 3175527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• 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: 03/19/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2023
• 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 Sex: Unknown