MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP PROTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: associated product information: cer option type 1 tpr sleve +3 catalog #: 650-1067 lot #: 2959184, medical product: g7 dual mobility liner 44mm f catalog #: 110024464 lot #: 535710, medical product: act artic hd arcom xl 28x44mm catalog #: xl-200150 lot #: 473080.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the patient suffered a hip dislocation.The hip could not be relocated, therefore a revision was performed.

Event Description

It was reported that the patient suffered a hip dislocation.The hip could not be relocated, therefore a revision was performed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.X-ray review: :eight radiographs were provided for analysis with (b)(4): one pre-operative anteroposterior x-ray; two post-primary ap x-rays; two ap x-rays taken after dislocation; one mediolateral fluoroscopy image after the implant was put back in place; and two post-revision ap x-rays.Their poor image quality makes it impossible to read dates.The inclination angle of the acetabular shell was measured (imagej v1.51k, nih, usa) in the full-pelvis post-primary ap x-ray to be 50 degrees.This is higher than the recommended inclination of 40 degrees [1], and may have contributed to the reported lateral dislocation.Surgical notes of the primary surgery ((b)(6) 2019) state that the cup was reamed in 15 degrees of anteversion and 45 degrees of abduction.The final 54 biomet g7 cup component was then impacted into the prepared acetabulum with excellent fit and fill and no instability.The cause of dislocation cannot be determined with certainty, but the high inclination angle of the acetabular cup may have been a contributing factor.The manipulation of the implant during relocation may have further contributed to its instability.The manufacturing history records (mhrs) for the biolox delta option head and the option type 1 sleeve have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.The manufacturing history records (mhrs) for the g7 dual mobility liner and the arcom xl liner were not provided and therefore could not be checked.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorised representative or the competent authority that the content of this report is complete or accurate, that the device(s) listed failed in any manner and/or that the device(s) caused or contributed to the alleged death or deterioration in the state of the health of any person.References: [1] 0004.3-glbl-en-rev1115.G7 dual mobility construct ¿ surgical technique.Biomet uk ltd.(2015).A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 1 similar complaints reported with these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Manufacturer Narrative

(b)(4).This final-follow up report is being submitted to relay additional information.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.It was reported approximately 2 months after undergoing tha, a patient suffered a hip dislocation.During attempts to relocate the hip in an er, x-rays demonstrated that the g7 dual mobility active articulation head and the 28mm femoral head implant had come apart.Therefore, the hip could not be relocated.Patient was taken to surgery where the g7 dual mobility implant was replaced with a standard g7 hi-wall liner.Liner was seated into the shell, and the biolox 28mm femoral head was inserted into the dual mobility articulating head per surgical technique.The most likely root cause of the superficial marks on the ceramic head is that is has come into contact with the hip cup, hip prosthesis or instruments.No other issues have been identified with this product (the product is conforming to specification).A review of the complaints database shows that we have received 13 reported events for dislocation for the same item number 650-1055 prior to the reported event.The severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is moderate risk.Capa: no corrective action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be field accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the patient suffered a hip dislocation.The hip could not be relocated, therefore a revision was performed.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9563374
• MDR Text Key: 174098075
• Report Number: 3002806535-2020-00007
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00088030452191
• UDI-Public: 088030452191
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 2957937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 93