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

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Ossification (1428); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Scar Tissue (2060); Synovitis (2094); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: 00631005032 61068597 liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells.00801803202 61957471 femoral head sterile product do not resterilize 12/14 taper.00620005022 614559121 shell porous with cluster holes 50 mm o.D.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.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 - 2021 - 02819, 0002648920 - 2021 - 00303.

Event Description

It was reported patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 8 years post implantation due to metal related pathology with memory loss, difficulties with adls, ambulating, instability, and pain.Surgeon noted corrosion, debris with locking mechanism not engaged.Revision of the head and liner was performed.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

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected reported event was confirmed by review of medical records received.Review of the available records identified a right total hip arthroplasty was performed.The patient began experiencing memory loss, difficulty ambulating, and other symptoms related to metal pathology.A revision occurred, where corrosion was found.The stem was stable and trunnion was cleaned of black debris, but ho was noted around the stem and shell.The prior liner was not fully engaged.No complications were noted, and the head and liner were replaced with zimmer products.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.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.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED
• 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: 12589616
• MDR Text Key: 275149489
• Report Number: 0001822565-2021-02820
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 00771100500
• Device Lot Number: 61851938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/07/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2011
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White