MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE CEMENTED CUP S46; HIP PROSTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that patient underwent revision surgery of the hip approximately four (4) month post-op due to the cup loosening after patient's fall.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Product was not returned or pictures not provided.Device evaluation could not be performed.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.This device is used for treatment.Medical records were not reviewed as they were nor provided.A definitive root cause cannot be determined but it has been noticed that the avantage cup has been implanted with an incompatible inlay.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 CEMENTED CUP S46
• 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: 15102316
• MDR Text Key: 296562520
• Report Number: 3006946279-2022-00084
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: 00887868524547
• UDI-Public: (01)00887868524547(17)260606(10)0001563770
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: P0463046
• Device Lot Number: 0001563770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization