MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to dual mobility implant disassociation when the bearing disassociated from the head, approximately two (2) years, three (3) months from initial surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10 - cer option type 1 tpr sleve -3 item#650-1065, lot#3050891.Act artic e1 hip brg 28x44mm item#ep-200150, lot#022880.G7 dual mobility liner 44mm f item#110024464, lot#639140.G2 ¿ foreign ¿ japan.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were not provided.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.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 17457387
• Report Number: 3002806535-2023-00266
• Device Sequence Number: 7236582
• Product Code: LZO
• UDI-Device Identifier: 00887868271373
• UDI-Public: (01)00887868271373(17)301228(10)3050659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2023

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: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3050659
• Was Device Available for Evaluation?: No
• 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: 07/14/2023
• Initial Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• 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: Prefer Not To Disclose