MAUDE Adverse Event Report: BIOMET UK LTD. OLYMPIA FMRL IMPLANT RIGHT SZ3; OLYMPIA LEGACY STEMS 12/14

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(4).Product has been requested to be returned to zimmer biomet for investigation.Medical product: m2a-magnum mod hd sz 48mm, catalog #: 157448, lot #: 1103467.Medical product: ha m2a-magnum pf cup 54odx48id, catalog #: 157954, lot #: 1133642.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that when a false movement was made, the patient felt an immediate slap and sharp pain as well as functional impotence.A control x-ray revealed a neck fracture of the prosthesis.Subsequently, a revision surgery was required with a femorotomy for removal of the implants and placement of the new implants (prosthesis fracture).Date of the incident has not been reported.

Event Description

It was reported that when a false movement was made, the patient felt an immediate slap and sharp pain as well as functional impotence.A control x-ray revealed a neck fracture of the prosthesis.Subsequently, a revision surgery was required with a femorotomy for removal of the implants and placement of the new implants (prosthesis fracture).Date of the incident has not been reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the r&d for investigation.An olympia femoral stem, an m2a magnum femoral head, an m2a magnum taper adaptor and a recap/magnum acetabular shell were revised due to fracture of the femoral stem after approximately 14 years in use, after a false movement made by the patient, although it is not clear what this was.Major surgery was required with a femorotomy for removal of the implants and placement of new implants.One full-pelvis anteroposterior radiograph was provided for analysis with (b)(4).The x-ray was taken on an unknown date, but the fractured femoral stem is visible, which means it was taken prior to revision surgery.The body of the femoral stem appears adequately sized and cemented in the femoral canal.Email communications provided with (b)(4) state that the surgical technique for the product was utilised.The inclination angle of the m2a-magnum shell was measured to be 41.2° in the provided radiograph, which is lower than the recommended surgical inclination angle in the m2a-magnum surgical technique: 45 degrees of inclination.Email communications provided with (b)(4) indicate that the patient was male, 56 years old, weighed 92 kg and was 1.66 m tall, thus having a bmi of 33.4 (obese).It is also stated that perhaps the slight over weight of the patient was a contributing condition related to the event, which happened after a false movement.The cause of the adverse event cannot be determined without post-primary x-rays, surgical notes of both primary and revision surgeries, and analysis of the revised components.However, the patient¿s weight may have been a contributing factor.The olympia femoral stem fractured across its neck, with fracture surfaces presenting beach marks that indicate a fracture mechanism due to mechanical fatigue initiated at the laser etched marking site.The bearing surfaces of the m2a magnum head and recap/magnum acetabular shell were in overall good condition, except from some minor scratches and indentations likely caused by instruments during revision.The manufacturing history records of the olympia femoral stem and recap/magnum acetabular shell have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.Warnings in packaging insert that excessive loading of the replaced joint could result in loss of implant mechanical integrity.The olympia hip risk management file documents the estimated residual risk associated with the reported event.The severity of the reported event (necessitates surgical intervention) is in line with the risk file, and no issue with the occurrence rate (remote) has been identified, therefore the overall score is low risk.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: OLYMPIA FMRL IMPLANT RIGHT SZ3
• Type of Device: OLYMPIA LEGACY STEMS 12/14
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11371364
• MDR Text Key: 233251065
• Report Number: 3002806535-2021-00048
• Device Sequence Number: 1
• Product Code: JWH
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P0124003
• Device Lot Number: 67707
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 92