MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AURA II FEMORAL STEM SIZE 6; PROTHESIS, HIP

Catalog Number NOT COMMUNICATED

Device Problems Material Erosion (1214); Device Appears to Trigger Rejection (1524); Unstable (1667); Loss of Osseointegration (2408); Biocompatibility (2886); Device-Device Incompatibility (2919); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Debris, Bone Shedding (1803); Fall (1848); Inflammation (1932); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).List of associated devices : magnum cup, reference and batch unknown, handle in (b)(4), manufactured by biomet (b)(4) ltd; cobalt chrome head, reference and batch unknown, handle in (b)(4), manufactured by biomet (b)(4) ltd.Establishment name : (b)(6).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 patient's legal representative that the patient was implanted with an aura ii stem, a crco head and a magnum acetabular component on (b)(6) 2010.Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.On (b)(6) 2017, the patient fell and the prosthesis has decompensated.It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.It was reported that the metal friction between the prosthesis components has led to inflammatory granulomas with a phenomen of bone resorption.On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.Based on current data it cannot be determined whether both the acetabular system and the hip stem were removed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.According to the information in the reported, the patient was implanted with a metal-metal couple prosthesis on (b)(6) 2010.It is stated that the x-ray shows that patient suffered from bipolar geodic reaction following a release of ions by the prosthesis.Indeed, the metal friction between the prosthesis components has led to inflammatory granulomas with a phenomenon of bone resorption.The product analysis can't be performed as the product was not returned.The review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.The instruction for use have been reviewed and it was noticed that the magnum cup used is not part of acetabular components that can be used with aura ii stem.Indeed, only cmk, apollo, avantage, alize ii or eternity are recommended.A complaint extract was done regarding revision due to pain, inflammation, bone resorption and metallosis: 1 complaint (1 product), this one included, has been recorded on aura ii femoral stem right size 6, from january 01, 2017 to february 18, 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.Investigation results concluded that the reported event was due to user error (magnum acetabulum component not compatible with aura ii femoral component).A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

Event Description

It was reported through patient's legal representative that the patient was implanted with an aura ii stem, a crco head and a magnum acetabular component on (b)(6) 2010.Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.On (b)(6) 2017, the patient fell and the the prosthesis has decompensated.It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.It was reported that the metal friction between the prosthesis components has led to inflammatory granulomas with a phenomen of bone resorption.On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.Based on current data it cannot be derrmined whether both the acetabular system and the hip stem were removed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections have been updated : b4, g3, g6, h2.The following section has been corrected : h6, h10.According to the information in the reported, the patient was implanted with a metal-metal couple prosthesis on (b)(6) 2010.It is stated that: the x-ray shows that patient suffered from bipolar geodic reaction following a release of ions by the prosthesis.Indeed, the metal friction between the prosthesis components has led to inflammatory granulomas with a phenomenon of bone resorption.It was not possible to verify the allegations made and whether it was caused by the aura ii femoral stem, because there are no medical records including x-rays and results of tissue examinations and there are also no explants made available.Therefore, the review is limited to quality documentation.The review of the device manufacturing quality can't be performed as the product reference and batch number was not communicated.A complaint extract was done regarding revision due to pain, inflammation, bone resorption and metallosis: (b)(4) complaint ((b)(4) product), this one included, has been recorded on aura ii femoral stem right size 6, 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.The product analysis can't be performed as the product was not returned the instruction for use have been reviewed and it was noticed that the magnum cup used is not part of acetabular components that can be used with aura ii stem.According to available data, root cause of the event was unable to be determined.However, it can be noticed that the whole device was not compatible.Indeed, the magnum acetabulum component used is not compatible with the aura ii femoral component.The complaint is closed but could be reopened if new information is received later.A summary of the investigation has been sent to the patient.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.

Event Description

It was reported through patient's legal representative that the patient was implanted with an aura ii stem, a crco head and a magnum acetabular component on (b)(6) 2010.Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life.On (b)(6) 2017, the patient fell and then the prosthesis has decompensated.It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis.It was reported that the metal friction between the prosthesis components has led to inflammatory granulomas with a phenomen of bone resorption.On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis.Based on current data it cannot be derrmined whether both the acetabular system and the hip stem were removed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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 patient underwent initial right total hip arthroplasty subsequently, the patient was revised approximately 10 (ten) year later due to pain, difficulties, and instability.The patient was reported to have loosening and osteolysis of the acetabular cup as well as osteolysis of the proximal femur with significant bone loss requiring bone grafting and osteosynthesis stabilization during the revision.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 information.Medical records and radiographs were provided and reviewed by a health care professional.It has been found that patient began to experience pain in the right thigh with a feeling of instability approximately 8 years 4 months post-op.A year later the patient reports painful episodes in the right hip, especially when getting in/out of the car.Infection was ruled out with aspiration, x-ray showed osteolysis, and acetabular revision was recommended.Subsequently, 19 days later it was identified that the right hip has a loosened prosthesis requiring a cup change and bone graft of the femoral shaft.Approximately 4 months later, the ct shows right hip osteolysis at the proximal femur with acetabular loosening and osteolysis, which led to revision surgery.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: AURA II FEMORAL STEM SIZE 6
• Type of Device: PROTHESIS, HIP
• 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 ; .; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11055851
• MDR Text Key: 223164469
• Report Number: 3006946279-2020-00243
• Device Sequence Number: 1
• Product Code: OQI
• 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: Other,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NOT COMMUNICATED
• Device Lot Number: NOT COMMUNICATED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 83 KG