MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICROP LAT FMRL 9.0MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 11-363662 36mm cocr mod hd std lot# 618180, item# ep-108323 e-poly 36mm +3 hiwall lnr sz23 lot# 619330, item# pt-116052 regen/rnglc+ ltd 52mm sz 23 lot# 480870.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05488.

Event Description

It was reported a patient underwent right hip arthroplasty.Subsequently, the patient was revised approximately 5 years post initial implantation due to pain, heterotopic ossification, pseudocapsule, periprosthetic fracture, poor bone quality, and implant (cup) malposition.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4).Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records indicate right hip pain.She had signs of stress reaction around the stem.Present was heterotopic ossification and malposition of her acetabular component.No obvious signs of infection.Several cultures were sent to microbiology (no report).A pseudocapsulotomy was performed.Femoral stem was well fixed.It was removed without iatrogenic bone loss.The patient¿s lateral cortex was found to be thin.Upon maneuvering the hip, a non-displaced fracture of the greater trochanter just below the vastus ridge was identified.Extensive heterotopic ossification was noted and removed.Acetabulum was found to be vertical and retroverted.The acetabulum was removed without iatrogenic bone loss.There was a silver dollar sized medial wall defect.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 MICROP LAT FMRL 9.0MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9435207
• MDR Text Key: 169796006
• Report Number: 0001825034-2019-05487
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• PMA/PMN Number: K121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2019
• 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: 15-103203
• Device Lot Number: 050760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• 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