MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET MAGNUM FEMORAL HEAD; HIP PROSTHESIS

Catalog Number S001140

Device Problems Corroded (1131); Material Erosion (1214); Metal Shedding Debris (1804); Naturally Worn (2988)

Patient Problems Fall (1848); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Reaction (2414); Fluid Discharge (2686)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: item # 11-106056, shell, lot # 689230, item #, ep-108524, liner, lot # 640580, item #, 13-103200, stem, lot # 519370, item #, 31-32323o, drill bit, lot # 709050, item #, 103533, screw, lot # 815530, item #, 103532, screw, lot # 526530.Attorney.Reported event was confirmed by review of x-rays and medical records provided.Pre-revision radiograhps demonstrate a well fixed left total hip arthroplasty without lysis or asymmetric polyethylene wear.No evidence of loosening.There does appear to be some increased fluid collection and lateral to the greater trochanter and under the iliotibial band in the location of the trochanteric bursa.Device history record was reviewed and no discrepancies were found.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 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 5 years post initial implantation, due to patient allegations of pain, metallosis, altr, elevated ion levels, necrosis, stiffness, pseudotumor and implant wear causing corrosion.Attempts have been made, and no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint was previously confirmed by x-rays and medical records received.Additional medical records received further confirms complaint.Operative record identified patient with pain in left hip and groin.The patient's images show fluid collection bursa, mild tenderness over greater trochanter.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: BIOMET MAGNUM FEMORAL HEAD
• Type of Device: HIP PROSTHESIS
• 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: 7402483
• MDR Text Key: 104548107
• Report Number: 0001825034-2018-01637
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK062997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

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: Physician
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: S001140
• Device Lot Number: 628700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2006
• 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: 78 YR
• Patient Weight: 102