MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK TRILOGY SCREW; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Reaction (2414); Osteopenia/ Osteoporosis (2651); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04585, 0001822565-2019-04717, 0001822565-2019-04718, 0001822565-2019-04719.

Event Description

It was reported that a patient underwent a left tha.Subsequently patient experienced bilateral hip pain, instability, difficulty with ambulation and underwent revision of left hip approximately 21 years later.During the revision surgeon notes significant bone erosion, cup loosening, migration and fragments of screws along with metallosis stained tissue that required debridement.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Reported event was confirmed with operative notes provided.Revision notes demonstrated the following: metallosis stained soft tissue-debrided, cup migrated & loose, fragments of prior screws explanted, thin bone/defects trials completed, final components showed excellent stability.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.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 event information available at the time of this report.

• Brand Name: UNK TRILOGY SCREW
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9273276
• MDR Text Key: 181557163
• Report Number: 0001822565-2019-04722
• Device Sequence Number: 1
• Product Code: KWA
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD 12/14 TAPER CAT#00801802801 LOT#NI; LINER 7 MM OFFSET 28 MM CAT# 00614105028 LOT#NI; SHELL POROUS 50 MM O.D.CAT# 00620005022 LOT#NI; UNK NECK CAT#NI LOT#NI; UNK STEM CAT#NI LOT#NI; UNK TRILOGY SCREW CAT#NI LOT# NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 127