MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE 3P ACETABULAR CUP / CEMENTLESS/ SIZE 62; ACETABULAR SHELL

Catalog Number P0461062

Device Problem Off-Label Use (1494)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).No further information provided (x-rays, surgical report, photographs, lab test).The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The instructions for use have been reviewed and it is mentioned that the expiry date is printed on the label.It was also mentioned not to use implants after the expiry date.A complaint extract was done regarding expired product implanted: 1 complaint (1 product), this one included, has been recorded on avantage 3p acetabular cup / cementless/ size 62, reference (b)(4), from january 01, 2018 to may 06, 2021.1 complaint (1 product), this one included, has been recorded on avantage 3p acetabular cup / cementless/ size 62, reference (b)(4), batch 0001100130.Investigation results concluded that the reported event was due to user error (product implanted after expiry date).A summary of the investigation was sent to the complainant conveying proper instructions for use of the device.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 1 expired product has been consumed in a surgery when the product was being invoicing.Indeed, the product expired on 22 feb.2021 and was used in a surgery on (b)(6) 2021.The sales agent reported that some days before the surgery, he removed from the stock products expired or near to expired, which were introduced in a box, however, someone else put them back to the shelves by mistake or ignorance thinking that they were new products.No adverse health consequences has been reported for the patient but it can be noticed that the department manager of the hospital leaves the information written in the history of the patient in case he will show any problem in the future.

• Brand Name: AVANTAGE 3P ACETABULAR CUP / CEMENTLESS/ SIZE 62
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11790210
• MDR Text Key: 252183184
• Report Number: 3006946279-2021-00078
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

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 Expiration Date: 02/22/2021
• Device Catalogue Number: P0461062
• Device Lot Number: 0001100130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1