MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source : journal article, foreign - event occurred in lithuania.Reference: stucinskas, justinas, kalvaitis, tomas, smailys, alfredas, robertsson, otto & taraseviciusv sarunas (2017) comparison of dual mobility cup and other surgical construts used for three hundred and sixty two first time hip revisions due to recurrent dislocations: five year results from lithuanian arthroplasty register.International orthopaedics 42:1015¿1020.Https://doi.Org/10.1007/s00264-017-3702-0.12 revisions were mentioned in the article: 5 for dislocations, 5 for infection, 1 for periprosthetic fracture, 1 for cup loosening.However it is not possible to determine if these events involve avantage cup (zimmer biomet) or quatro vps (groupe lépine).This complaint is for one of the revisions due to infection.The device was not returned to the manufacturer.Therefore it could not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.According to the available data, it cannot be determined if a zimmer biomet product was involved in this event and the exact root cause could not 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.Device not returned.

Event Description

Journal article reported that patient underwent revision surgery due to infection on avantage cup.

• Brand Name: AVANTAGE CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL CEMENTED ACETABULAR COMPONENT)
• 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: hélène bataille ; plateau de lautagne bp75; valence 26903 ; FR 26903 ; 0334757591
• MDR Report Key: 8285519
• MDR Text Key: 134352857
• Report Number: 3006946279-2019-00071
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention