MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK B 12/14 NECK TAPER; PROSTHESIS HIP

Catalog Number 00784802200

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

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial left tha and was later revised due to pain.Within the joint, there was extensive adhesion and scarring, as well as gray material present at the head-neck junction, consistent with trunnionosis.Upon removal of the stem, a crack was noted in the greater trochanter, which developed into a fracture during the osteotomy.There was limited wear on the liner, and excellent stability/rom was noted upon completion.The liner, stem, head, and neck were explanted, and all but the liner were replaced with competitor's products.Device history record (dhr) was reviewed and no discrepancies were found.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 concomitant medical products: part# 00771300700/modular femoral stem press-fit/lot# 60778207.Part# 00631005032/ liner/lot# 60794814.Part# 00801803202/ head/lot# 60785478.Part# 00620205422/ shell/lot# 60757822.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2021 -00314, 0001822565 -2021 -03080, 0001822565 -2021 -02875.

Event Description

It was reported that patient underwent left hip revision surgery 10 years post implantation due to pain.During the revision, scarring, gray material, trunnionosis, and wear was noted.Trochanteric fracture occurred upon removal of the stem.The shell remained intact.The head, liner, stem, and neck were removed and replaced.No further event information available at the time of this report.

• Brand Name: MODULAR NECK B 12/14 NECK TAPER
• 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: 12673640
• MDR Text Key: 277688912
• Report Number: 0001822565-2021-03078
• Device Sequence Number: 1
• Product Code: LZO
• 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: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 00784802200
• Device Lot Number: 60694676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2007
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR