MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical product: cer option type 1 tpr sleve -6, catalog #: 650-1064, lot #: 265000.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00088.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient had an initial right hip replacement.Subsequently, the patient was revised due to complications with metal on metal implants.Patient was again revised due to leg length discrepancy.This complaint is reporting the revision due to the leg length discrepancy.Attempts were made to obtain additional information; however, none was available.

Event Description

It was reported that the patient had an initial right hip replacement.Subsequently, the patient was revised due to complications with metal on metal implants.Patient was again revised due to leg length discrepancy.This complaint is reporting the revision due to the leg length discrepancy.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: cer option type 1 tpr sleve -6, catalog #: 650-1064, lot #: 265000.Medical product: m2a-magnum recap cup 58odx52id, catalog #: 157858, lot #: 043360.Medical product: act artic e1 hip brg 28x52mm, catalog #: ep-200158, lot #: 235260.Medical product: m2a-magnum 52-60mm tpr insrt-6, catalog #: 139264, lot #: 004100.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00088-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or 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 these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports hip revision due leg length discrepancy.Risk management report documents the estimated residual risk associated with the reported event.The root 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.The reported event states hip revision due leg length discrepancy.The severity score is 3, which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.Therefore, the outcome of the reported event (surgical intervention) is in line with the rmf.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9727200
• MDR Text Key: 180332828
• Report Number: 3002806535-2020-00089
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K082996
• 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: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• 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: 650-1055
• Device Lot Number: 727470
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention