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.

Event Description

It was reported that: a patient underwent a revision surgery due to intraprosthetic dislocation of the right total hip prosthesis.

Manufacturer Narrative

(b)(4).The product was returned and lab analysis was performed.Medical records were provided.The reported event was confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The products involved in the complaint are compatible.Complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part/lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were reviewed and show that patient underwent a revision surgery on (b)(4) 2021 following a periprosthetic fracture of the femur.Then, on (b)(4) 2021, the patient underwent a medical intervention to reduce a luxation of the prosthesis.Finally, patient was revised on (b)(4) 2021, patient suffered from pain and it was noticed that the prosthesis dislocated, that led to a revision surgery on (b)(4) 2021.A definitive root cause cannot be determined.No further actions have been initiated as a result of the reported event investigation.

Manufacturer Narrative

(b)(4).D10 - list of associated devices: cocr fm hd d28/ 12-14/0/ m, reference p0206m28, batch j6787299.Uption comp stem l220 s4 d13 r, reference p0167413, batch 0001364370.Avantage reload cup ti ha s54, reference p0460p54, batch 0001484128.Uption comp locking pin l.35mm, reference p0160035, batch 0001504673.Uption comp locking pin l.35mm, reference p0160035, batch 0001462952.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, a patient underwent a revision surgery due to 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: Lay User/Patient
• 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 Sequence Number: 1
• Treatment: ASSOCIATED DEVICE MENTIONED IN H10.; ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR