MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; HIP PROSTHESIS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# (b)(4).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that the wrong size implant ceramic head was implanted into the patient.Subsequently, the surgeon commented on the sizing of the font suggesting its difficult to be seen if standing 4-5 feet away.The patient was revised on the same day to the correct size ceramic head.

Event Description

It was reported by the hospital that the wrong size implant ceramic head was implanted into the patient.Subsequently, the surgeon commented on the sizing of the font suggesting its difficult to be seen if standing 4-5 feet away.The patient was revised on the same day to the correct size ceramic head.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The event reports that the wrong size ceramic head was implanted.The surgeon comments that the identification of the product is very difficult after a change to product labelling.This event occurred during surgery.The complaint has not been confirmed following review of the photographs provided, which confirmed the label is to specification and in line with labelling standards.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified no similar/similar complaints for the same item number.A complaint history review identified no similar/similar complaints for the same lot number.Risk score not required at the reported event has not been confirmed.The severity score associated with the potential harm of non-functioning joint is 3 (moderate) with an occurrence score of 2 (between 1 in 10,000 and 1 in 100,000) as per severity and occurrence tables within the rmr.The severity of the reported event is in line with this risk file.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states.The condition of the device when it left zimmer biomet is conforming to specification.The label is to specification and is in line with regulatory requirements.No corrective action has been initiated as the reported event has not been confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9370263
• MDR Text Key: 167831192
• Report Number: 3002806535-2019-00899
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115120
• Device Lot Number: 2971262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• 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: 52 YR
• Patient Weight: 32