MAUDE Adverse Event Report: ZIMMER BIOMET, INC. R/C II CONSTRAINED LINER SZ 23; PROSTHESIS, HIP

Model Number N/A

Device Problems Off-Label Use (1494); Naturally Worn (2988)

Patient Problems Pain (1994); Tissue Damage (2104); Ambulation Difficulties (2544)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: biomet lot# 105423 cat#443850 na rnglc locking ring sz 23; biomet cup cat#unk lot# unk; stryker stem and head.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: revision surgery d/t wear of articular bearing surface 500-1000 ml of brownish fluid.No abductor attachment to femoral stem and no host bone.'more a rind with in the femur.' all 'devitalized' tissue evacuated.Protrusio noted.Consult w/urology for assessment and left tissue alone for later removal in a supine position or possibly get smaller.Area on trunnion where the cup was rubbing which caused a little bit of erosion on trunnion which could have been a source of metal debris.Cage placed, femoral component remains.Multiple screws placed as well as constrained liner with locking ring.Rom testing shows flexion contracture of 40 degrees with internal rotation to be 20 and external rotation 0.Hip flexion 60 degrees with internal rotation to 30 and external rotation to 20.Estimated that case took 200% additional time due to complexity of the case.A review of the device history records identified no deviations or anomalies during manufacturing for the liner.A definitive root cause cannot be determined, however, it is possible the use of the competitor's head and the stem could have caused or contributed to the event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 04182.

Event Description

It was reported the patient underwent a right total hip arthroplasty.Subsequently, patient was revised approximately 11 years later due to a loose femoral component.The patient has undergone a second revision approximately 15 years later due to recurrent dislocations.Recently, the patient was revised approximately 1 year later due to pain, protrusio, tissue damage and bone loss.It was noted the case took 200 percent additional time due to complexity of the case.No further event information available at the time of this report.

• Brand Name: R/C II CONSTRAINED LINER SZ 23
• 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: 11164776
• MDR Text Key: 226642216
• Report Number: 0001825034-2021-00081
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 11-107003
• Device Lot Number: 423860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75