MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE INSERT E1 DIAMETER 28 SIZE 50; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)

Model Number N/A

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products and therapy date detail of product: item number 00784802300, item name kinectiv modular neck g, lot # 6395804; item number 65771301200, item name modular femoral stem 12.5 hatcp, lot # 63771596; item number p0460p50, item name avantage reload acetabular shell ss ha 50mm, lot # 0001215954; item number 00801802802, item name femoral head +0x28mm dia, lot # 63015862.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported that a patient underwent an initial hip procedure on (b)(6) 2018.Subsequently the patient was revised on (b)(6) 2018 due to infection.The liner and head components were removed and replaced.

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer.Therefore it could not be analyzed the device manufacturing quality record indicates that the released product met all requirements to perform as intended.According to the available data, the exact root cause of the event cannot be determined.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

Please refer to report 3006946279 -2018 - 00426.

• Brand Name: AVANTAGE INSERT E1 DIAMETER 28 SIZE 50
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8247567
• MDR Text Key: 133044571
• Report Number: 3006946279-2018-00426
• Device Sequence Number: 1
• Product Code: KWA
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/29/2022
• Device Model Number: N/A
• Device Catalogue Number: P0561E50
• Device Lot Number: 0001231005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/06/2019
• 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