MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN CERAMIC HEAD; UNKNOWN KNEE ARTHROPLASTY

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Product requested but not returned by hospital.Concomitant medical products: medical product: g7 osseoti 4 hole shell 58mm g, catalog #: 110010247, lot #: unknown.Medical product: g7 screw 6.5mm x 35mm, catalog #: 010001000, lot #: 6603768.Medical product: g7 dual mobility liner 46mm g, catalog #: 110024465, lot #: 949920.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial hip arthroplasty, the ceramic head chipped when impacting the ceramic head bearing construct onto the femoral stem.The surgeon required a new ceramic head implant and new dual mobility bearing implant.A backup dual mobility bearing was not available and the surgeon decided on an alternative implant option which resulted in a 45 minute delay in surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Biomet uk ltd have attempted to gather information however, we have not been able to retrieve any further information relevant to this complaint.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.We have not been provided with x-rays or any supporting documentation which could provide additional information.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

It was reported that during an initial hip arthroplasty, the ceramic head chipped when impacting the ceramic head bearing construct onto the femoral stem.The surgeon required a new ceramic head implant and new dual mobility bearing implant.A backup dual mobility bearing was not available and the surgeon decided on an alternative implant option which resulted in a 45 minute delay in surgery.

• Brand Name: UNKNOWN CERAMIC HEAD
• Type of Device: UNKNOWN KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10361011
• MDR Text Key: 204719038
• Report Number: 3002806535-2020-00356
• Device Sequence Number: 1
• Product Code: HRY
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• 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: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1