MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER FEM HD 32/+6MM T1; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); Foreign Body In Patient (2687)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item# 4245; lot# 3113735e22; allofit alloclas shell 52/ii.Item# 0100013409; lot# 3107098; dural alpha insert neutr ii/32.Item# 51-103100; lot# 7027094; tprlc 133 t1 pps so 10x140mm.G2 ¿ foreign ¿ netherlands.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately 2 years post-implantation, x-rays confirmed that the head was not on the stem.The patient underwent revision surgery due to a fractured ceramic head.The cup, liner, and head were removed and replaced.The stem remained implanted.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
This report is being submitted to correct the b5 and h6 in the previous medwatch report (3002806535 -2024 - 00241).
Event or Problem Description
It was reported that approximately 2 years post-implantation, surgeon confirmed that the head was not on the stem.The patient underwent revision surgery due to a fractured ceramic head.The cup, liner, and head were removed and replaced.The stem remained implanted.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
This report is being submitted to correct the b5 and h6 in the previous medwatch report (3002806535 - 2024 - 00241-1).
Event or Problem Description
It was reported that approximately 2 years post-implantation, surgeon confirmed that the head was not on the stem.The patient underwent revision surgery due to a fractured ceramic head.The cup, liner, and head were removed and replaced.The stem remained implanted.A tiny ceramic particle was left in the patient.Attempts have been made and all additional information received has been included in this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual review of the returned ceramic head confirms that it is fractured with 6 pieces returned.Not all pieces appear returned.The two larger pieces when set together appear to have chips at the top of the spherical head.Nicks, scratches, abrasion marks, and discoloration are noted to the taper hole, outer spherical surface, and fracture surfaces.No other damage was noted.The head was sent for fracture analysis, and it was reported as follows: the returned device was reviewed with visual examination and optical microscopy using a digital microscope.Analysis of images.Examination of the fractured head images 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.Radiographs were provided (three views of the right hip (2 pre-revision & 1 post-initial implant)) and reviewed by a radiologist.The review identified a right total hip arthroplasty with fractured ceramic head with small fracture fragments noted along the inferior joint space as well as dissociation of the femoral head from the femoral stem.No signs of loosening.No osteolysis.Acetabular cup is horizontal in appearance with suggestion of a small inclination angle.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 report 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: BIOLOX DELTA CER FEM HD 32/+6MM T1
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• 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: 19642600
• Report Number: 3002806535-2024-00241
• Device Sequence Number: 7092780
• Product Code: LZO
• UDI-Device Identifier: 00887868271540
• UDI-Public: (01)00887868271540(17)320404(10)3107683
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K200959
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2024

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 Model Number: N/A
• Device Catalogue Number: 650-1160
• Device Lot Number: 3107683
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 06/18/2024; 11/11/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/15/2024; 07/17/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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 H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown