MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. CHROME COBALT FEMORAL HEAD D32 / 12-14 / -4 / S; METALLIC FEMORAL HEAD PROSTHESIS

Catalog Number P0206C32

Device Problem Off-Label Use (1494)

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

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that a product expired on (b)(6) 2022 and was used in a surgery on (b)(6) 2022.As per hospital statement, the implant was opened by mistake in a surgery prior the expiration date and following the instructions of the hospital it was sterilized again (the hospital aimed to maintain the sterility for 6 months more) and it was implanted in the surgery.This decision was taken by the hospital, who assessed that in no moment the sterility was lost and it did not induce any type of the infection to the patient.No adverse health consequence has been reported as the result of the event.

Manufacturer Narrative

(b)(4).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 review of the sterilization certificate indicates that the products were sterilized according to the specification.No other similar event was recoded on the reference.Investigation results concluded that the reported event was due to user error (expired product implanted).A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, the complaint will be reopened.Zimmer biomet will continue to monitor for trends.

• Brand Name: CHROME COBALT FEMORAL HEAD D32 / 12-14 / -4 / S
• Type of Device: METALLIC FEMORAL HEAD PROSTHESIS
• 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: 13729656
• MDR Text Key: 289956765
• Report Number: 3006946279-2022-00022
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2022

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: 01/16/2022
• Device Catalogue Number: P0206C32
• Device Lot Number: J3923955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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