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

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Metal Related Pathology (4530)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat#00-6310-060-32 xlpe 10 deg poly liner 60x32, lot#63619382.Cat#00-8018-022-02, femoral head +0x22mm dia.Cat#00-6200-060-22 f/m acet shell 60mmod cluster, lot#63663753.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: 0002648920 - 2020 - 00547.

Event Description

It was reported that patient underwent left total hip arthroplasty.Subsequently, patient underwent a revision procedure due to metallosis or trunnions type of reaction and pain.There was no metal debris in the superficial fluid, but it was not normal in appearance.There was mild wear of the trunnion with some very mild metal debris around the inside of the femoral head.The acetabular cup was noted to be well fixed.The polyethylene liner and head were removed and replaced.No additional information.

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 initial report should reflect that the correct date for g4 is december 14, 2020.

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 updated: b4, b5, d4, g3, h2, h3, h6 reported event was confirmed by review of medical records.Medical records were provided and reviewed by a healthcare professional.The patient underwent an initial left tha on (b)(6) 2017 due to severe oa; no intraoperative complications identified.The patient was revised on (b)(6) 2019 due to pain and metal related pathology.Mri showed significant inflammatory fluid around the hip however no evidence of purulence or metal debris.There was mild wear of the trunnion with some very mild metal debris around the inside of the femoral head.Polyethylene intact without gross wear.Locking ring was functional.Acetabular cup was well fixed.Pathology study showed ischemic necrosis, chronic inflammation, and negative for acute inflammation or neoplasm.Labs taken (b)(6)2019 and(b)(6) 2019 showed elevated cobalt and chromium levels.Device history record (dhr) was reviewed and no discrepancies 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 proposed component code: mechanical (g04)-stem.Review of complaint history identified additional similar complaints for the head, no additional complaints for the stem, and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged.This complaint was confirmed based on the provided medical records and returned head.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

There is no update to the prior event description provided.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER PLASMA
• 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: 11101895
• MDR Text Key: 224584692
• Report Number: 0001822565-2020-04270
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00771101010
• Device Lot Number: 63652605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male