MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 50MM BIOMET CUP; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988); Migration (4003)

Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Tissue Damage (2104); Ambulation Difficulties (2544)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet, lot#: 105423, cat#443850, na rnglc locking ring sz 23, biomet, lot#11-107003, cat#423860, na r/c ii constrained liner sz 23, stryker stem and head.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

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.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.'able to bring the cup in its line around with gentle manipulation and medial to this there was a well encased tissue layer which i felt was the adverse local tissue reaction but i felt that opening this up would not be wise as this was extended from right lower quadrant all the way to the left lower quadrant in the abdomen/pelvis.' 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.Part and lot identification are necessary for review of device history records, neither were provided.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 - 2021 - 00081.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN 50MM BIOMET CUP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10895802
• MDR Text Key: 217999514
• Report Number: 0001825034-2020-04182
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75