MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer bone scr 6.5x35 self-tap, cat#: 00625006535, lot#: 62935956.Zimmer bone scr 6.5x25 self-tap, cat:#: 00625006525, lot#: 62893291.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00440, 0002648920 - 2020 - 00441, 0002648920 - 2020 - 00442.

Event Description

It was reported the patient underwent an initial left total hip arthroplasty.Subsequently, the patient underwent a revision surgery approximately 5 years later due to pain, difficulty ambulating/new prescribed use of assistive device, and suspected femoral component loosening.Intraoperatively, altr, necrosis, trunnionosis, and loose femoral component with no bony ingrowth were encountered.The initial cup was well fixed and remains implanted.The liner, head and stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a revision procedure due to failed hip arthroplasty.Per the office notes, the patient was suffering from pain and was using a cane to walk.Altr was observed during the revision procedure, and devitalized tissue was debrided from the joint.There was corrosion at the head-trunnion junction.The femoral stem was loose and had no bony ingrowth.The head, liner, stem, and locking ring were replaced with new zimmer biomet components.No other complications/findings related to the event was noted.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10626180
• MDR Text Key: 209766399
• Report Number: 0001822565-2020-03419
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K192660
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771101620
• Device Lot Number: 62771072
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• 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 Weight: 84