MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM M2A MOD HEAD STD NK; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01307.

Event Description

It was reported that a patient underwent hip revision approximately 18 years post implantation due to high elevated ion metals and multiple pseudo tumors.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Review of the available records identified the following: right hip demonstrates a right total hip arthroplasty with cement fixation of the acetabular cup.No radiolucency along the acetabular cup.Rounded lucency along the greater trochanter could suggest osteolysis or postsurgical change.Heterotopic ossification along the lateral acetabulum.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.

Event Description

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

• Brand Name: 28MM M2A MOD HEAD STD NK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8441388
• MDR Text Key: 139538274
• Report Number: 0001825034-2019-01306
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K993438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 11-163662
• Device Lot Number: 057200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET M2A CUP CATALOG#15-104054 LOT#012090; BIOMET M2A LINER CATALOG#15-105000 LOT#171360; BIOMET PLUG CATALOG#135300 LOT#008110; BIOMET STEM CATALOG#180006 LOT#000610
• Patient Outcome(s): Hospitalization; Required Intervention