MAUDE Adverse Event Report: ZIMMER BIOMET, INC. STEM NH COLLARED 12/14 1 R; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Swelling (2091); Tissue Damage (2104); Reaction (2414)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer hip system femoral head (ref.No.00801803202, lot no.62268545), zimmer trilogy longevity constrained liner (ref.No.00-6334-056-32, lot no.62148214), zimmer metal modular acetabular system (ref.No.6202-56-22, lot no.62186326).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: 0001822565 -2019 -04460 head, 0001822565 -2019 -04466 cup, 0001822565 -2019 -04467 liner.

Event Description

It was reported by legal that patient underwent an initial right hip arthroplasty and subsequently revised five years later due to heterotopic ossification.A fair amount of black material was noted on the trunnion and the inside of the head, consistent with metallosis.There was also mention of a confirmed pseudotumor and surgeon noted the cup was not in the ideal position.During work-up 3-dimensional imaging confirmed a large pseudotumor in his iliac fossa.During work-up patient developed an acute dvt with a large amount of swelling of his right lower extremity.Per surgeon: this was a direct result of compression on his iliac vein.Cardiovascular surgeon removed the pseudotumor separately a few weeks prior to revision.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 was reviewed and no discrepancies were found.Root cause was unable to be determined.Medical records and radiographs identified the following: patient presented with significant swelling and a procedure to relieve pressure on iliac vein was completed.During workup three dimensional imaging confirmed a large pseudotumor in his iliac fossa.During workup patient developed an acute dvt with a large amount of swelling of his right lower extremity.This was a direct result of compression on his iliac vein.Ivc filter placed.Cardiovascular surgeon removed the pseudotumor separately a few weeks prior.This will remain part of this complaint, as the pseudotumor is related to metallosis and surgeon stated that the dvt was a direct result of compression of his iliac vein by the pseudotumor.Large amount of scar tissue that was very dense.Soft tissue debridement was significant.A large portion of the superior capsule was removed as some it had developed into heterotopic ossification.A large amount of the inferior capsule was removed as well.Black material on both the trunnion and the inside of the head ball consistent with metallosis.It appeared that the locking mechanism of the liner was not functioning properly.An attempt was made to pull the tabs apart but they were already partially apart.An osteotome was used to segment liner away which allowed surgeon to deform the liner enough to remove.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: STEM NH COLLARED 12/14 1 R
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9201334
• MDR Text Key: 163140125
• Report Number: 0001822565-2019-04464
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K970300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 735402201
• Device Lot Number: 62177154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 03/17/2020
• Supplement Dates FDA Received: 03/30/2020
• 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