MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FEMORAL STEM; PROSTHESIS HIP

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Osteolysis (2377); Reaction (2414); No Information (3190)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices.Unk femoral head.Unk cup.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10686.It is unknown if product will be returning to zimmer biomet and 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 was revised due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported that the patient was revises approximately 8 years post initial surgery due to metallosis and femoral stem loosening.Extended trochanteric osteotomy for removal of femoral stem and open reduction and internal fixation of extended trochanteric osteotomy with cables was performed.Significant resorption of femoral bone from metallosis, loosening of femoral stem and trunnionosis to previous femoral stem was seen.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical products: m2a-magnum mod hd #, lot 122080, item: (b)(4); m2a-magnum pf cup #, lot 716730, item: (b)(4); m2a-magnum 42-50mm, tpr insrt # lot 749640, item: (b)(4).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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision op notes provided.Review of revision op notes states that severe metallosis, severe metallic debris throughout the femoral acetabular joint including down the femoral canal, posterior soft tissues, femoral bone, femoral acetabular joint, and partial encasement of adductor musculature.Significant resorption of femoral bone from metallosis.Loosening of femoral stem.Trunnionosis to previous femoral stem.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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

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

• Brand Name: TAPERLOC POR FEMORAL STEM
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8068708
• MDR Text Key: 127060089
• Report Number: 0001825034-2018-10687
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-103204
• Device Lot Number: 069720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .
• Patient Outcome(s): Hospitalization; Required Intervention