MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER SIZE 12.5 STANDARD OFFSET; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Muscle/Tendon Damage (4532)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Implant date: 2013.Concomitant medical devices: part: unk head, lot: unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00346.

Event Description

It was reported the patient alleges pain and elevated ion levels approximately eight years post implantation.A revision has not yet been scheduled.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It as reported patient underwent a revision procedure 7 years and 9 months post-implantation due to continued elevated metal ions, gluteus medius tear, and trunnionosis.The surgeon noted presence of black material deposited around the femoral head and trunnion and gross failure of prior gluteus medius repair.The trunnion was found to be corroded with deposition of black material inside the head and over approx.50% of the trunnion.Only the femoral head was replaced.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right total hip arthroplasty procedure on (b)(6) 2013 due to arthritis.Unknown zimmer biomet components were implanted without any complications.Lab reports dated (b)(6) 2017 revealed elevated metal ions in the blood - cobalt 10.6 (normal <1.9), chromium 4.0 (normal <3.6).Lab reports dated (b)(6) 2021 also revealed elevated metal ion levels - cobalt 9.4 (normal <= 1.8), chromium 8.1 (normal <3.6).Trunnionosis was observed during the revision procedure.Liner was not replaced as there was no wear.Trochanteric debridement and gluteal repair were performed.The metal femoral head was removed and a new ceramic head was implanted.No other finding/complication related to the reported event was noted.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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.

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.

Event Description

No further event information available at the time of this report.

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.Reported event was confirmed due to the review of medical records.Additional medical record information shows minimal lucency around the distal femoral stem measures up to 1 mm and is new since the previous exam.The femoral stem is also slightly posterior in the femoral diaphysis.This could represent hardware loosening.Multiple surgical clips project over the right inguinal region device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.Additional information does not change the root cause of previous investigation.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

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER SIZE 12.5 STANDARD OFFSET
• 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: 11314572
• MDR Text Key: 231394676
• Report Number: 0001822565-2021-00345
• 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,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00771101200
• Device Lot Number: 62316461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2013
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG