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); Insufficient Information (3190)

Patient Problems Neonatal Deformities (1974); Pain (1994); Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377); Reaction (2414); No Information (3190); No Code Available (3191)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog# 00630505032 liner standard 32 mm i.D.For use with 50/52/54 mm o.D.Shells lot# 62047783, catalog# 00801803203 femoral head sterile product do not resterilize 12/14 taper lot# 61969297, catalog# 00620005422 shell porous with cluster holes 54 mm o.D.Lot# 62021107.The event was confirmed with medical records received.Post implantation there was a dislocation of hip.Blood test reports revealed serum chromium level of 3.0 and an elevated cobalt level of 7.5.Findings from mri report revealed a large joint effusion with thickening of the synovium and advance atrophy of the glutes and tearing of the distal tendons.Review of revision operative notes stated chronic instability, brown and necrotic tissue consistent with metallosis.Corrosion at the trunnion and of the femoral head at the morse taper and some osteolysis around the acetabular cup rim were also noted.The stem and cup were found to be well fixed.The head and liner(for stability) were revised.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: 0001822565-2016-04875, 0001822565-2016-04855.

Event Description

It was reported a patient underwent a revision procedure approximately four years post implantation due to dislocation, osteolysis, in-vivo corrosion, elevated metal ion levels, pain, tendon tear, tissue damage, instability, and necrosis.No further event information available at the time of this report.

• 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: 9193213
• MDR Text Key: 162661406
• Report Number: 0001822565-2019-04450
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771100920
• Device Lot Number: 61986026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2012
• 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 Weight: 86