MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE INLAY S54 / 28 NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER

Catalog Number P0561054

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Report source, foreign - event occurred in (b)(6). Concomitant medical products - list of associated devices: cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference (b)(4), batch j6787299. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported, that there was an intraprosthetic dislocation of the right total hip prosthesis.

• Brand Name: AVANTAGE INLAY S54 / 28
• Type of Device: NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
• 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: 13106207
• MDR Text Key: 282893504
• Report Number: 3006946279-2021-00213
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: P0561054
• Device Lot Number: 0001511683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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 Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1