MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPER EXT OFFSET RED NECK 10; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060); No Information (3190); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 0001822565 - 2021 - 00317.

Event Description

It was reported that the patient underwent a left hip revision procedure approximately eight years and 4 months post-implantation due to unknown reasons.No additional information.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6b - it was reported in operative notes received that the device was not removed during the procedure.

Event Description

It was reported the patient underwent a left hip arthroplasty subsequently developed left hip pain, and was treated for hip infection.Approximately 8 years post implantation the patient underwent a revision procedure due to tissue/muscle absent, as well as necrosis and yellow fluid under the fascia.Corrosion and wear were reported to the trunnion/head.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.D10: versys femoral head -3.5 (00-8018-028-01, 61548508); natural tm monoblock acetabular cup/liner (00-7255-048-28, 61581089).Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a left tha was performed.A revision occurred after being treated for an infection previously.Tissue damage was found as well as a pseudotumor, with corrosion at the base of the femoral head.Antibiotic beads were placed.The shell, liner, and head were explanted with no complications noted.Device history record (dhr) was reviewed and no discrepancies were found.Root cause remains unchanged.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.Reported event was confirmed due to the review of medical records.Additional medical records provided show that blood work collected dhow metal ions were elevated, with a cobalt level of 2.9.Device history record (dhr) was reviewed and no discrepancies were found.Root cause remains unchanged.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is unlikely that the specified device caused any patient infection.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.

• Brand Name: TAPER EXT OFFSET RED NECK 10
• 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: 11278074
• MDR Text Key: 230222430
• Report Number: 0001822565-2021-00316
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/15/2022

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00771101040
• Device Lot Number: 61631843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 04/02/2021; 09/20/2021; 12/06/2021; 02/10/2022
• Supplement Dates FDA Received: 04/08/2021; 10/05/2021; 12/28/2021; 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2010
• 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
• Treatment: SEE H10 NARRATIVE; UNK VERSYS FEMORAL HEAD; UNKNOWN CUP; UNKOWN LINER; UNK VERSYS FEMORAL HEAD.; UNKNOWN CUP.; UNKOWN LINER.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female