MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CERAMIC FEM HD 36/+3MM; HIP IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: netherlands.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 a chip of the ceramic head has come off.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that patient underwent an initial hip procedure.Subsequently, the patient was experiencing pain, difficultly walking, grinding and popping and underwent a revision approximately 2 years post implantation due to a fractured ceramic head, possible trauma.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d2b, d4, d6, d10, e1, e3, g2, g3, g6, h2, h4, h6, h11.D10: item # 010000858, g7 neutral e1 liner 36mm f, lot # 7264168.Item # 010000664, g7 pps ltd acet shell 54fl, lot # 7268249.Item # 51-113140, tprlc 133 type1 bm so 14.0, lot # 7155777.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The product involved in the reported event was returned for investigation.Visual review of the returned ceramic head confirms the device to be fractured.5 pieces were returned.The fractured spherical edges show fragments that are missing and not returned.Black and yellow bio or foreign debris are noted on the fractured surfaces and taper hole.Marks are noted to the ceramic from possible metal transfer.The fractured head was sent for further analysis where it was reported that examination of the fractured head images provided shows metal transfer marks within the taper, as well as numerous metal transfer marks on all surfaces, likely from contact with the metal stem, acetabular shell and/or from contact with instruments during removal.The fracture surfaces looked irregular, with clean flat regions adjacent to rougher surfaces.The complexity of the fracture surfaces did not allow for the determination of the fracture initiation point.The root cause of the ceramic head fracture could not be determined in this instance.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.One radiographs was provided and reviewed by a radiologist.The review identified a single ap view of the bilateral hips demonstrating a right total hip arthroplasty with fragments noted inferior to the femoral head, possibly acetabular or from the femoral head.No bony fracture.Bony fusion of the symphysis pubis superiorly.Sizing and position of the right total hip arthroplasty is appropriate.Based on the available information, the reported event can be confirmed.A definitive root cause could not be determined.The complaint is reporting a possible trauma however no further information has been received regarding this.No corrective, preventive or field action was taken following the investigation of this event.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.

• Brand Name: DELTA CERAMIC FEM HD 36/+3MM
• Common Device Name: HIP IMPLANT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20364013
• Report Number: 3002806535-2024-00389
• Device Sequence Number: 3890166
• Product Code: JDI
• UDI-Device Identifier: 00887868271182
• UDI-Public: (01)00887868271182(17)320718(10)3122243
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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 Model Number: N/A
• Device Catalogue Number: 650-0662
• Device Lot Number: 3122243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 03/27/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/04/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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 Sex: Unknown