MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE E1 INLAY S58 / 28; HIP PROSTHESIS

Model Number N/A

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported that during the revision the liner did not fit in the socket.The procedure had to be completed using the explant, causing a 10 minutes delay.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: avantage e1 inlay s58 / 28 item #p0561e58, lot#0001567491.Report source: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).D10: p0206l28; cocr fm hd d28/ 12-14/ +3,5/ l; j6880195.The product was returned and lab analysis performed.No picture was provided.Dimensional analysis shows that the product is conforming to the specifications.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.This device is used for treatment.The head and the inlay are compatible.The implanted shell is not a zimmer biomet product.The instruction for use indicates that the recap /magnum acetabular cup in association with an avantage e1 inlay is for revision only.Therefore, the implants are not compatible.Medical records were reviewed and show that the patient had recurrent dislocations.Review of the available records show overall fit and alignment of the implants appears normal.There are signs of possible infection, although difficult to fully assess without comparative exams to determine changes from prior time points.With the information provided, we can conclude that the shell and the inlay implanted are not compatible regarding the instruction for use.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: AVANTAGE E1 INLAY S58 / 28
• Type of Device: HIP 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: 15958377
• MDR Text Key: 307107551
• Report Number: 3006946279-2022-00122
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868525001
• UDI-Public: (01)00887868525001(17)260608(10)0001567491
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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: P0561E58
• Device Lot Number: 0001567491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 COMMENT
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose