MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+6MM T1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total hip arthroplasty and subsequently, revision surgery was performed due to a femoral head fracture.Due diligence is in progress for this complaint.To date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10 - medical devices.Dural alpha insert neutr ii/32; item# 01.00013.409; lot# 3114031.Tprlc 133 t1 pps ho 15x150mm; item# 51-104150; lot# unknown.Allofit alloclas shell 52/ii; item# 4245; lot# 3121357.G2: foreign - europe : netherlands.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h11.Product was returned and assessed.The ceramic head was fractured approximately in half, with irregular fracture surfaces featuring clean flat regions adjacent to rougher surfaces.Numerous metal transfer marks were observed within the taper and on all surfaces, likely from contact with the stem, acetabular shell, or instruments during time in vivo and/or removal.The complexity of the fracture surfaces did not allow a determination of the fracture initiation point, making it impossible to determine the root cause of the ceramic head fracture.The neutral liner was also fractured approximately in half, with only the two major halves returned.Small ceramic fragments were embedded within the articulation surface.Significant scratching and gouging were noted on the articulation surface and rim, along with thinned and worn-through polyethylene near the pole of the reassembled liner.The backside of the liner exhibited significant scratching and gouging near the thinned area.It was concluded that the liner fracture was likely secondary to the head fracture; after the ceramic head fractured and the fragments moved or misaligned, the stem taper possibly bore directly on the articulation surface of the liner for some time, leading to its fracture.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.Complaints are monitored per complaint trending process.Radiographs were provided and reviewed by a radiologist.The review identified that a left hip arthroplasty is present.There is a comminuted fracture of the femoral head implant and there is ceramic debris at the inferior joint.The trunnion maintains alignment with the acetabular cup without dislocation.No implant loosening is identified.With the available information, a definitive root cause cannot 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: DELTA CER FEM HD 32/+6MM T1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER
• 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: 18510247
• Report Number: 3002806535-2024-00020
• Device Sequence Number: 20580904
• Product Code: LZO
• UDI-Device Identifier: 00887868271540
• UDI-Public: (01)00887868271540(17)320405(10)3111365
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192683
• 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
• Report Date (Section B): 06/18/2024

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: 3111365
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 06/18/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 02/07/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose