MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA CER LNR 36MM E; G7 CERAMIC LINER

Model Number N/A

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported, that: during a primary total hip replacement a ceramic liner fractured.Using hard bearing ring liner was placed in situ and then struck with liner impactor.The surgeon inspected and noted it wasn't seated properly due to soft tissue impingement.Whilst i left the room to get a suction piece to aid removal surgeon attempted to leave with a hohmann retractor and liner fractured.Patient outcome: prolonged surgery, delay: 5 minutes.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in australia.The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: during a primary total hip replacement a ceramic liner fractured.Using hard bearing ring liner was placed in situ and then struck with liner impactor.The surgeon inspected and noted it wasn't seated properly due to soft tissue impingement.Whilst i left the room to get a suction piece to aid removal surgeon attempted to leave with a hohmann retractor and liner fractured.Patient outcome: prolonged surgery, delay: 5 minutes.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The photograph provided confirms the liner has broken into 5 pieces and there are marks where a metallic object has come into contact with the liner.The product the has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.The dhr review showed that all released products are according to specifications valid at the time of production.Raw material certificate review confirms that the products are compliant with the specifications valid at the time of manufacturing.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A complaint history review identified three (3) similar complaints for item 110003634.Medical records/radiographs were not provided.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review did not identify any issues.The definitive root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.

• Brand Name: BIOLOX DELTA CER LNR 36MM E
• Type of Device: G7 CERAMIC LINER
• 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: 13860057
• MDR Text Key: 297863499
• Report Number: 3002806535-2022-00155
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110003634
• Device Lot Number: 3088101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 85 KG