MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM +6 NK; HIP PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

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.Medical product: tprlc 133 mp type1 pps so 12.0, catalog #: 51-106120, lot #: unknown.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that during an asi tha, the ceramic head fractured upon impaction.No fragmented pieces were retained by the patient.Surgery was completed with a second device.

Event Description

It was reported that during an asi tha, the ceramic head fractured upon impaction.No fragmented pieces were retained by the patient.Surgery was completed with a second device.

Manufacturer Narrative

(b)(4).This report is to relay additional information.Summary of ceram tec investigation: the density and grain size of the ball head were analysed and found to be complying with the delivery specification for bilox delta components.The microstructure as obtained from the quality documents fulfils the requirements as specified at the time of production, too.There are no indications of any pre-existing material defect.Secondary metal transfer can be found on the ball head as result of contact with metal parts or surgical instrument during the surgical procedures.The expected primary metal transfer on the bore of the ball head cannot be found equally distributed.This might indicate a disturbance at the interface between stem and ball head.Additionally, intensive stripes of metal transfer and metal transfer patterns of erratic appearance can be found on the bore surface.However, it cannot be ascertained, whether this metal transfer occurred prior to or after the primary fracture event.The primary fracture surfaces and the region of fracture origin can be identified.The region of fracture origin is located at a small pattern of intense metal transfer in zone e.Such intense metal transfer indicates a small area of intensive contact between the ceramic ball head and metal object.Material analyses revealed that the expected primary metal transfer on the bore surface of the ball head and stipe of metal transfer at the fracture origin contain titanium, leading to the conclusion that patterns were caused by contact with the metal stem.A local point landing at the interface between metal stem taper and ball head potentially caused the fracture of the ball head.However, the cause of the point load could not be determined.A review of the manufacturing history records confirms no abnormalities or deviations reported.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: CER BIOLOXD MOD HD 36MM +6 NK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9414930
• MDR Text Key: 169355842
• Report Number: 3002806535-2019-00902
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 12-115123
• Device Lot Number: 2965001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1