MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NK TPR PLSM SZ 12.5 STD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Failure of Implant (1924); Pain (1994); Tinnitus (2103); Metal Related Pathology (4530)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00801803202- femoral head sterile product do not resterilize 12/14 taper- 62326128 00630505832-liner standard 32 mm i.D.For use with 58 mm o.D.Shell- 62301828 unknown-unknown shell-unknown multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00401.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.

Event Description

It was reported patient underwent a left hip revision due to metallosis during the procedure the head and liner were revised without complication.No allegations against liner, surgeon said the poly looked good.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records; neither were provided for the stem.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated updated: b4; b5; d6; g3 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

It was reported that a patient underwent a left hip revision approximately 9 years post implantation due to metal related pathology.During the procedure, the head and liner were replaced without complications.

Event Description

It was reported a patient underwent a left hip revision approximately nine years post implantation due to a concern for systemic symptoms of metallosis, pain and elevated metal ion levels.During the procedure, corrosion to the trunnion and slightly to the femoral head was noted as well.The head and liner were exchanged without and further apparent complications.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.Dhr was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed, with no complications noted.A revision occurred due to elevated metal ions and pain.During the revision corrosion was noted on the base of the trunnion and femoral head.The head and liner were explanted and replaced with no complications noted.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.

• Brand Name: FEMORAL STEM 12/14 NK TPR PLSM SZ 12.5 STD
• 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: 13507800
• MDR Text Key: 285666410
• Report Number: 0001822565-2022-00402
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00771101200
• Device Lot Number: 62201849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male