MAUDE Adverse Event Report: BIOMET UK LTD. MOD HD COCR 22.22/ 0MM (T1); METALLIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical devices: medical product: mlry-hd 3hole rlc shl 48mm/l22, catalog #: 11-104148, lot #: 333766; medical product: arcom rnglc lnr 22mm hwall 22, catalog #: 11-105982, lot #: unknown; medical product: bi-metric por fmrl 9.0x300mmr, catalog #: 162360, lot #: 582270.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00440.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

It was reported that the patient underwent a hip arthroplasty sometime in 2003.The patient has experienced a fall, and plans to be revised due to an implant fracture.

Event Description

It was reported that the patient underwent a hip arthroplasty sometime in 2003.The patient has experienced a fall, and plans to be revised due to an implant fracture.Patient still in hospital awaiting for revision.The femoral stem is fractured.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00440-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Radiographs: one anteroposterior radiograph of the patient left hip was provided with (b)(4) for analysis.Although the precise date is not known, it is assumed to have been taken prior to revision surgery, given that the distal part of the femoral stem is fractured, as well as an adjacent fracture of the proximal medial femoral diaphysis being observed in this radiograph.Implant size and alignment appear adequate; however it is not possible to comment on the positioning of the acetabular shell, given that full-pelvis x-rays (immediate post-primary and/or prior to the trauma incident) have not been provided.Bone fragments appear to be present both medially to the acetabular shell (in the pelvis) and laterally in the joint space.The origin of the bone debris is unclear, but it is possible that the reported fall may have contributed to the fracture of adjacent pelvic bones into multiple fragments.The information available states that the patient received the femoral stem in 2003 ¿ the patient was operated from in another hospital another visiting surgeon long ago.No access to his old notes.The patient, female and 58 years old at the time of the adverse event, experienced a fall and plans to be revised due to an implant fracture.A technical report from zimmer biomet product surveillance (dated 24 november 2020), attached to linked complaint (b)(4), states that the combination of products reported in this complaint have been confirmed to be approved/cleared for use and is a legally marked combination.This combination would not be expected to contribute to the reported issue.The maven md¿ reviewer case report by medical metrics inc.(for (b)(4)) states that there is a fracture of the femoral stem and a comminuted femur fracture.The tip of the femoral implant is not included on the image.The bones are osteopenic and there is extensive abnormal radiolucency of the proximal femur of uncertain etiology and the fracture appears to be pathologic.The medial acetabular fixation screw extends through the medial wall and into the pelvic soft tissues.Additionally, marked abnormal radiolucency of the proximal femur suggesting a pathologic fracture.This report also states that mild polyethylene liner wear is noted, likely because the femoral head appears to be eccentric relatively to the acetabular shell.It is not possible to determine the cause of the adverse event without surgical notes, full-pelvis x-rays, patient details (height, weight, activity level) and/or analysis of the explanted components.However, it is likely that the fall experienced by the patient was a major contributing factor to the fracture of the femoral stem.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 11-104148 and 1 similar complaints reported with the item 164440.A review of the complaint database over the last 3 years has found no similar complaints reported with these item and lot combination.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports history of fall and prosthesis broke.The rot cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.As stated in the complaint summary, it is likely that the fall experienced by the patient was a major contributing factor to the fracture of the femoral stem.A risk line cannot be assigned in i/o risk tables (mallory shells fmea 2017 or cocr femoral heads 538322 risk table as the complaint is concerned with the fracture of the femoral stem and not the functionality of the shell (item 11-104148) or head (item 164440).The reported issue (implant fracture) is addressed on linked complaint (b)(4).No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: MOD HD COCR 22.22/ 0MM (T1)
• Type of Device: METALLIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10625560
• MDR Text Key: 209764330
• Report Number: 3002806535-2020-00441
• 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: 01/08/2021

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: 164440
• Device Lot Number: 326806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• 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: 58 YR