MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. VARIZED FEMORAL STEM EXCEPTION -CEMENTLESS- 542- 12/14 - LEFT S5; COATED HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PV126Y05

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices: cobalt chrome femoral head 5°42 ø28 / 0 / 12-14/ col moyen, reference p0206m28, batch j6214037; avantage reload acetabular cup / cementless / size 56, reference p0460p56, batch 0001165540; avantage inlay size 56 ø 28, reference p0561056, batch 0001180858.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 that patient underwent a revision surgery on (b)(6) 2021 due to aseptic loosening 3 years post-operatively.It was also reported by the sales representative who assisted to the revision surgery that the metaphysal loosening was probably due to a malpositioning of the stem.

Event Description

It was reported that patient underwent a revision surgery on (b)(6) 2021 due to aseptic loosening 3 years post-operatively.It was also reported by the sales representative who assisted to the revision surgery that the metaphysal loosening was probably due to a malpositioning of the stem.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No further information provided (x-rays, surgical report, photographs, lab test).The product analysis can't be performed as the product was not returned.Therefore, the reported event could not be confirmed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding revision due to loosening: 1 complaint (1 product), this one included, has been recorded on varized femoral stem exception -cementless- 5°42- 12/14 - left s5, reference pv126y05, from january 01, 2018 to june 23, 2021.1 complaint (1 product), this one included, has been recorded on varized femoral stem exception -cementless- 5°42- 12/14 - left s5, reference pv126y05, batch 0001108099.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 has been transmitted to the customer.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VARIZED FEMORAL STEM EXCEPTION -CEMENTLESS- 542- 12/14 - LEFT S5
• Type of Device: COATED HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 11964848
• MDR Text Key: 255066082
• Report Number: 3006946279-2021-00090
• Device Sequence Number: 1
• Product Code: KWY
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: PV126Y05
• Device Lot Number: 0001108099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ASSOCIATED DEVICES LISTED IN H10.
• Patient Outcome(s): Hospitalization; Required Intervention