MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD -3MM NK; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); Osteolysis (2377)

Event Date 06/06/2019

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: 0001825034 - 2019 - 04970, 0001825034 - 2019 - 04971.

Event Description

It was reported that a patient underwent an initial right total hip arthroplasty.Subsequently, the patient underwent a revision approximately 16 years later due to pain, dislocation, elevated metal ions, and swelling.During the revision procedure, altr, metallosis, and head/neck corrosion was noted.Osteolysis was noted about the greater trochanter.The metal head was replaced with a ceramic head, and dual mobility construct with a titanium sleeve was implanted without complication.Pre-operative infection workup was negative.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was confirmed with operative notes provided.Revision op notes demonstrated the patient underwent a revision due to pain, dislocation, elevated metal ions, and swelling.During the revision procedure, altr, metallosis, and head/neck corrosion was noted.Osteolysis was noted about the greater trochanter.The metal head was replaced with a ceramic head, and dual mobility construct with a titanium sleeve was implanted without complication.Pre-operative infection workup was negative.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.

• Brand Name: M2A 38MM MOD HD -3MM NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9276462
• MDR Text Key: 166135711
• Report Number: 0001825034-2019-04969
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K062997
• 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 Expiration Date: 05/28/2013
• Device Model Number: N/A
• Device Catalogue Number: 11-173661
• Device Lot Number: 421510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: M2A 38MMX52MM CUP CAT#RD118852 LOT#394060; MLRY-HD LAT POR FMRL CAT#11-104210 LOT#174310
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79