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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Joint Dislocation (2374); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog#: 00801803201 femoral head -3.5x32mm dia lot#: 61394013, catalog#:00631005632 xlpe 10 deg poly liner 56x32 lot#:60819048.The event was confirmed with medical records received.Medical records identified, patient experienced severe pain along with 3 dislocations in one month and 1 self-reported dislocation with self reduction performed post implantation.The patient had elevated metal ions with corrosion noted on trunnion.Significant necrosis and tissue damage, along with pseudotumor was noted during the revision.The head and liner were removed and new ceramic head and rim liner 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.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00658, 0001822565-2019-03828.

Event Description

It was reported patient underwent a revision procedure approximately eight years post implantation due to dislocations including a dislocation with self reduction performed, elevated metal ions with corrosion noted on trunnion.Significant necrosis and tissue damage, along with pseudotumor.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9638114
• MDR Text Key: 176655634
• Report Number: 0001822565-2020-00376
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771101100
• Device Lot Number: 61512804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR