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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 06/20/2023

Event Type  Injury  

Event Description

It was reported that patient underwent hip prostheses implantation.Subsequently, nine (9) months later, revision surgery was performed to remove the spacer and to put revision prosthesis in situ.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G-2 foreign: australia.D10: avantage cemented cup s58, item# p0463058, lot# 1626979.Zb 12/14 cocr hd 28mm x +3.5, item# 802202803, lot 3047459.Cpt 12/14 size 3 cocr ext, item# 00-8114-003-10, lot 65270823.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.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed.The reported event of unspecified infection occurred >90 days post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection given this information, this medwatch will be voided.

Event Description

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed.The reported event of unspecified infection occurred >90 days post implantation.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection given this information, this medwatch will be voided.

Event Description

It was reported that patient underwent hip prostheses implantation.Subsequently, nine (9) months later, due to infection, revision surgery was performed to remove the spacer and to put revision prosthesis in situ.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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.

• 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: 17324001
• MDR Text Key: 319027139
• Report Number: 3006946279-2023-00065
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00887868525001
• UDI-Public: (01)00887868525001(17)250705(10)0001490803
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 09/21/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: P0561E58
• Device Lot Number: 0001490803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/02/2023; 09/18/2023
• Supplement Dates FDA Received: 08/25/2023; 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose