MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 11MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problems Ossification (1428); Pain (1994); Scar Tissue (2060); Synovitis (2094); Reaction (2414)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet m2a-magnum pf cup 58odx52id cat#us157858 lot#152030; biomet m2a-magnum mod hd sz 52mm cat#157452 lot#617100; biomet taperloc micro lat fmrl 11mm cat#15-103205 lot#635750; biomet m2a-magnum 52-60mm tpr insrt-3 cat#139266 lot#198660.The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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 - 2020 - 03528, 0001825034 - 2020 - 03529, 0001825034 - 2020 - 03531.

Event Description

It was reported the patient had an initial right tha.Subsequently, the patient was revised approximately 9 years later due to pain, synovitis, scar tissue, and bone remodeling (sclerotic bone).It was noted that fifteen minutes was spent trying to remove the femoral head as it appeared to be cold-welded.The surgeon went to the backup plan and removed the entire stem.The head, liner, cup and stem were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: painful rtha with metal-on-metal articulation.Extensive synovitis around hip.Significant metal fusion of the femoral head onto the femoral stem with inability to remove requiring greater trochanteric osteotomy with complete conversion of the right femoral stem.Significant right hip and knee pain.Limitations of activity due to pain.Multiple exams including images indicate possible femoral stem loosening along with questionable reaction to metal-on-metal sensitivity.Fifteen minutes was spent trying to remove the femoral head as it appeared to be coldwelded.The surgeon went to the backup plane and removed the entire stem.There was no significant looseness of the femoral stem.Femoral stem removed without significant bone loss.Significant sclerotic bone at the very distal aspect of the femoral stem which was removed.Significant scar tissue around the sciatic nerve.Good rom and stability with final products.No intra-operative complications noted.A review of the device history records identified no deviations or anomalies during manufacturing.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.

• Brand Name: TAPERLOC MICRO LAT FMRL 11MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10546606
• MDR Text Key: 207320008
• Report Number: 0001825034-2020-03530
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062994
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 15-103205
• Device Lot Number: 635750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/12/2020
• 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
• Patient Age: 37 YR