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

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 08/27/2023

Event Type  Injury  

Event Description

It was reported that approximately two months post-implantation of left total hip arthroplasty, the patient was revised due to a 28mm head disassociation from a 44mm bearing that was implanted.The patient had abductor insufficiency and dislocated.It is believed that the head disassociated from the dual when the event happened, or when an attempt was made to relocate it.It was noted that surgical technique was utilized, and the dual was assembled properly during the original surgery.The patient was converted to a constrained product.Due diligence is in progress for this event; to date no further information has been provided.

Manufacturer Narrative

(b)(4).D10: cer opt type 1 tpr sleve 0mm; ref#650-1066; lot#3050938.Vivacit-e dm bearing 28x44mm; ref#110031012; lot#65781071.G7 dual mobility liner 44mm f; ref#110024464; lot#949240.Arcos con sz a std 50mm; ref#11-301300; lot#65788746.Bone scr 6.5x30 self-tap; ref#00625006530; lot#j7421000.Arcos 14x150mm spl tpr dist; ref#11-300814; lot#65938420.G7 osseoti 4 hole shell 56mm f; ref#110010246; lot#65616938.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided picture identified a mark on the surface of the ceramic head.Nothing can be gained from the photograph of the head with regards to cause of the reported dislocation.A review of the device manufacturing records confirmed no abnormalities or deviations.The 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 28MM
• Type of Device: 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: 17780840
• MDR Text Key: 323832319
• Report Number: 3002806535-2023-00312
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 3114832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG