MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK E2 12/14 NECK TAPER USE WITH +0 HEADS ONLY; PROSTHESIS, HIP

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02869 and 0002648920-2023-00251.D10: cat# 00-7713-011-00 lot# 61684370 mod ml taper fem st 11.Cat# 00-8757-048-01 lot# 61514529 continuum tm shell clust 48 gg.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it¿s been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty.Subsequently, the patient was revised approximately 11 years due to recurrent dislocations, instability, and pain.During the revision noted impingement of the neck hitting the cup and trochanteric.The stem and shell were well fixed and remained implanted.The head, neck, and liner were exchanged without complications.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.A revision occurred due to recurrent dislocations, pain, and instability.During the rom evaluation, it was identified the neck was impinging on the cup.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: anatomic alignment of the left hip arthroplasty.Osteopenia.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 information at the time this report.

• Brand Name: MODULAR NECK E2 12/14 NECK TAPER USE WITH +0 HEADS ONLY
• 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: 17950814
• MDR Text Key: 325862477
• Report Number: 0001822565-2023-02870
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 00784802101
• Device Lot Number: 61704179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2011
• 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.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 61 KG