MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH MULTI HOLES; PROSTHESIS, HIP

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); Pain (1994)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00630505036 liner offset 61813278; 00625006525 bone screw 61770046; 00625006515 bone screw 61715983; 00801803603 femoral head 61782358.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location is unknown.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: 0002648920-2019-00186, 0002648920-2019-00187; 0002648920-2019-00188.

Event Description

It was reported that a patient was revised approximately 4 years post operatively with findings of heterotopic ossification, bearing wear and fracture, with prosthetic loosening of the acetabular cup.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records received.Revision operative notes demonstrated that the patient was revised on the left side due to pain, popping, heterotopic ossification of the greater trochanter, liner wear, and cup loosening.There was a lot of fretting.Synovial tissue hypertrophy was completely eroded and black, and was from the wear of liner.Super lateral portion of the liner was fractured and displaced.Superior part of the cup has no bone ingrowth.The cup was well fixed at the end to inferior aspect of the acetabulum.Three screws were removed.New cup, liner and head were implanted.Dhr was reviewed and no discrepancies relevant to the reported event 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.

• Brand Name: SHELL POROUS WITH MULTI HOLES
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8412342
• MDR Text Key: 138530435
• Report Number: 0001822565-2019-01109
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00620205220
• Device Lot Number: 61682635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• 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