MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM +3 NK; HIP PROSTHESIS

Model Number	12-115122
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: item#: 010000742; item name: g7 neutral arcomxl lnr 36mm g; lot#: 6109134.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 4 years post implantation of left hip arthroplasty, the patient experienced a work related fall and suffered a clavicle fracture as a result of the fall.After the fall, the patient began experiencing squeaking during ambulation, along with slight discomfort.The patient was subsequently revised.During the revision, it was noted that the femoral head was wearing against the shell.The head and liner were exchanged, with the surgeon exchanging the liner from a size 36 to 40.Due diligence is in progress for this complaint; to date no additional information has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product/provided pictures identified that the serial number on the head matches the c of c from the supplier.The item number is not marked on the part.There is damage to the coating of the head almost over the entire head.There are scratches to the face of the head on the serial number side.Dimensional analysis shows that the taper depth, the height and diameter of the head is conforming and matches the print.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: a left hip arthroplasty is anatomically aligned without fracture or dislocation.There is eccentric position of the prosthetic femoral head laterally within the acetabular cup consistent with polyethylene liner wear.Eccentric position of the prosthetic femoral head laterally within the acetabular cup consistent with polyethylene liner wear.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: CER BIOLOXD MOD HD 36MM +3 NK
• 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: 17105637
• Report Number: 3002806535-2023-00185
• Device Sequence Number: 12238976
• Product Code: LZO
• UDI-Device Identifier: 00887868248498
• UDI-Public: (01)00887868248498(17)290117(10)2971570
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 06/23/2023

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: 12-115122
• Device Catalogue Number: 12-115122
• Device Lot Number: 2971570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2019
• 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 Age: 64 YR
• Patient Sex: Male