MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NK PRESS-FIT SZ 7.5; PROSTHESIS, HIP

Catalog Number 00771100720

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Necrosis (1971); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 12/23/2019

Event Type  Injury  

Event Description

It was reported that a patient underwent a right hip revision approximately nine years post implantation due to chronic instability.During the procedure, it was confirmed that the patients hip joint easily dislocated.There was also extensive necrotic bone and tissue that required debulking and debridement.Fluid accumulation, corrosion, muscle damage and a large pseudotumor were found.The head and liner were removed and replaced without further complication.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2022-00150, 0002648920-2023-00149.D10: cat #: 00630505036, liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells, lot #: 61354997; cat #: 00801803602, femoral head sterile product do not resterilize 12/14 taper, lot #: 61401792.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: b4; b5; g3; h2; h3; h6.Proposed component code: mechanical (g04)- stem.Dhr was reviewed and no discrepancies related to the reported event were found.This complaint is confirmed based on the provided medical records.Root cause is 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.

• Brand Name: FEMORAL STEM 12/14 NK PRESS-FIT SZ 7.5
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17307339
• MDR Text Key: 318928896
• Report Number: 0001822565-2023-01792
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 00771100720
• Device Lot Number: 61171199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female