MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Local Reaction (2035)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 65771101620 femoral stem 12/14 neck taper plasma 60500985.00630505840 liner standard 3.5 mm offset 60951607.00620205822 shell porous with cluster holes 58 mm 60880562.00625006535 bone scr 6.5x35 self-tap 60980983.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The 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: 0001822565 - 2020 - 02224.

Event Description

It was reported patient underwent right hip revision approximately ten years post implantation due to metal related pathologies.During the procedure, altr and pseudotumor were noted, head and liner components were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Updated: b4, b5, b6, g4, h2, h3, h6.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 identified the following : the patient underwent a right total hip arthroplasty due to degenerative arthosis.Zimmer biomet products were implanted without any complications.The patient underwent a revision procedure due to metal related pathologies.The patient had elevated metal ion levels prior to revision : co level 4.4 and cr 3.3.Mri revealed a complex heterogenous mass around the capsule indicative of pseudotumor.During the procedure, fair amount of pseudotumor and hypertrophied capsular tissue was observed in the joint space.Large discoloration of a dark gray color along the tissue lining that could easily be debrided.The head and liner were replaced with new zimmer biomet devices.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 10194441
• MDR Text Key: 196398673
• Report Number: 0002648920-2020-00316
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K953337
• 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: 09/22/2020

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: 03/17/2018
• Device Model Number: N/A
• Device Catalogue Number: 00801804003
• Device Lot Number: 60940037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 09/23/2020
• 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