MAUDE Adverse Event Report: BIOMET UK LTD. BIOLOX DELTA LNR 32MM 50-52MM; BIOLOX DELTA XLW-18 LINER

Model Number N/A

Device Problems Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has been requested to be returned to zimmer biomet for investigation.(b)(6).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 surgery, the doctor tried many times to install biolox delta liner without success.It was found that the liner and the degree of fit was not enough.Another liner was used to complete the operation.No harm of the patient or the user was reported.Delay of surgery: 45 minutes.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.During the surgery, the doctor many times to install biolox delta liner cannot successfully installed into, by cleaning and disposal acetabulum edge cannot successfully installed, after knocking into the shell found that the liner and fit degree is not enough, take after replacing another liner to complete the operation, doubt the liner with a problem.During surgery, the doctor tried many times to install biolox delta liner without success.It was found that the liner and the degree of fit was not enough.Another liner was used to complete the operation.No health consequences.The most likely root cause is that the liner was not correctly aligned prior to impaction, this resulted in several attempts by the surgeon to align and impact the liner, subsequent too much force was used causing the damage to the rim and multiple scratches and marks on the taper and bearing surface.A review of the complaints database shows that we have received no reported events for liner would not seat for the same item number 650-0791 prior to the reported event.Risk assessment: the severity associated with the above line is 4.This gives a severity score of s-4 as per the rmr.The actual severity score is 2 as there was no patient harm but a delay to surgery.Occurrence rate assessment: january 2018 to january 2021: (b)(4) items sold.Number of similar incidents identified ¿ 1 (including initiating complaint).Occurrence ratio: 1:5611.Risk score: severity s1 x occurrence p2 = 2 (negligible risk).Risk assessment summary: the severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is low risk.No corrective or preventive actions are deemed necessary at this time.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.

Event Description

It was reported that during surgery, the doctor tried many times to install biolox delta liner without success.It was found that the liner and the degree of fit was not enough.Another liner was used to complete the operation.No harm of the patient or the user was reported.Delay of surgery: 45 minutes.

• Brand Name: BIOLOX DELTA LNR 32MM 50-52MM
• Type of Device: BIOLOX DELTA XLW-18 LINER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11272192
• MDR Text Key: 231142801
• Report Number: 3002806535-2021-00028
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 650-0791
• Device Lot Number: 2017101755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 50