MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hip revision on the same day as the initial implant due to a post-op dislocation.The liner and head were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).D10 ¿ tprlc 133 t1 pps so 20x160mm, item# 51-103200, lot#7244589.Hxpe liner neut 58 ll x 36, item# 00-8751-013-36, lot# 65501354.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Visual examination of the returned product identified metal transfer to the ceramic head which could be from both the dislocation and from the instruments where the head was attempted to be removed from the stem.The head is still attached to the stem.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional similar complaints for this item number.It should be noted however that physically the same device is included in an additional complaint, and reported in mfr 3002806535-2024-00105, where the head could not be removed from the stem taper upon revision after the dislocation which is investigated in this complaint (dislocation).Radiographs were provided and reviewed by a radiologist.The review identified that there is a left hip arthroplasty with a superolateral dislocation.The femoral head is anteriorly displaced on the cross-table lateral view, but the cup is not well visualized.There is no fracture.Other than the dislocation, no other implant failure is identified.The cup abduction angle measures approximately fifty-three degrees, at the upper limit of normal.With the available information, 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
It was reported that a patient underwent a hip revision on the same day as the initial implant due to a post-op dislocation.The head and stem were removed and replaced.Attempts have been made and no further information is available.

• Brand Name: BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM
• 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: 18928335
• Report Number: 3002806535-2024-00104
• Device Sequence Number: 4513310
• Product Code: LZO
• UDI-Device Identifier: 00887868271168
• UDI-Public: (01)00887868271168(17)330530(10)3159543
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/31/2024

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: 650-0660
• Device Lot Number: 3159543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male