MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION FEMORAL STEM; PROTHESIS, HIP

Catalog Number EXCEPTION FEMORAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).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 through siris outlier report 2020 on exception + exceed cups there was a revision due to periprosthetic fracture of the femure within two years after the first implantation.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Received data: no further information provided (x-rays, surgical report, photographs, lab test).Device history records: the review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.Complaint history : a complaint extract was done regarding revision due to periprosthetic fracture: 5 complaints (6 products), this one included, have been recorded on exception femoral stem, from (b)(6) 2017 to (b)(6) 2021.The complaint history, regarding the reference number, can't be performed as it was not communicated.The complaint history, regarding the batch number, can't be performed as it was not communicated.Device analysis : the product analysis can't be performed as the product was not returned.Conclusion: according to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.A summary of the investigation was sent to the complainant.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 through siris outlier report 2020 on exception + exceed cups there were two revisions due to periprosthetic fracture of the femur within two years after the first implantation.

• Brand Name: EXCEPTION FEMORAL STEM
• Type of Device: PROTHESIS, HIP
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 10983657
• MDR Text Key: 220692977
• Report Number: 3006946279-2020-00236
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: EXCEPTION FEMORAL STEM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: EXCEED CUP, REFERENCE AND BATCH UNKNOWN; EXCEED CUP, REFERENCE AND BATCH UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention