MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; HIP PROSTHESIS,SEMI-CONSTRAINED

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a left hip arthroplasty, and subsequently was revised due to recurring dislocations approximately 4 months after initial implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ ¿australia".D10 - medical product - g7 neutral e1 liner 36mm e; catalog #:010000857; lot#:7273174.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
(b)(4).D10: medical product: g7: bonemaster ltd acet shl 52e; catalog#: 010000703; lot#: 7268284.Tprlc 133 type1 bm ho 9.0; catalog#:51-114090; lot#: 3925856.This follow-up report is being submitted to relay additional and/or corrected information.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.Device is 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 40MM
• Common Device Name: HIP PROSTHESIS,SEMI-CONSTRAINED
• 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: 16893556
• Report Number: 3002806535-2023-00131
• Device Sequence Number: 6173650
• Product Code: LZO
• UDI-Device Identifier: 00887868271403
• UDI-Public: (01)00887868271403(17)320907(10)3127693
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 08/01/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 3127693
• 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: 05/01/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female