MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UNKNOWN INLAY

Model Number N/A

Device Problems Device Difficult to Setup or Prepare (1487); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Muscle/Tendon Damage (4532)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: germany.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during the revision, the liner did not fit in the socket.The procedure had to be completed with the explanted item causing a 10 minutes delay.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d9; g3; g6; h2; h6; h10.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported initial right total hip arthroplasty on an unknown date.Subsequently revised due to recurrent dislocations and questionable persistent periprosthetic infections.During the revision, cloudy secretions were encountered and debrided, and samples were sent to path.Lack of muscular stabilization resulted in reconstruction of muscle and fascia.The neck, head, and inlay were exchanged.The inlay would not seat exactly into the pan.Previously explanted inlay was reinserted.The patient remains on iv antibiotics for ten days and possibly oral antibiotics for 6-12 weeks.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 corrected information.It has been determined that the product that was previously reported was the device which the surgeon attempted to implant during the revision procedure.Details of the initially implanted device have not been provided.The product was not returned or pictures were not provided.Device evaluation could not be performed.The device manufacturing quality record could not be reviewed as the lot information was not provided.This device is used for treatment.A complaint history search could not be performed as the part and lot information was not provided.The head and the inlay are compatible.The implanted shell is not a zimmer biomet product.The instruction for use indicates that the recap /magnum acetabular cup in association with an avantage e1 inlay is for revision only.Therefore, the implants are not compatible.Surgical notes were provided and reviewed by a health care professional.Review of the available records indicate overall fit and alignment of the implants appears normal, recurrent dislocations with questionable persistence of a periprosthetic infection and lack of muscular stabilization.There are signs of possible infection, although difficult to fully assess without comparative exams to determine changes from prior time points.With the information provided, we can conclude that the shell and the inlay implanted are not compatible regarding the instruction for use.If any further information is found which would change or alter any conclusions or information, a follow-up report will be filled accordingly.

• Brand Name: UNKNOWN INLAY
• Type of Device: UNKNOWN INLAY
• 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: 15958387
• MDR Text Key: 308074296
• Report Number: 3006946279-2022-00121
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 01/24/2023
• Supplement Dates FDA Received: 01/09/2023; 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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): Other
• Patient Sex: Prefer Not To Disclose