MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TAPER 37/28MM LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Reaction (2414)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: pn 11-163662, ln 466620, 28mm m2a mod head std nk, item# unknown unknown stem lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 - 2018 - 08910.

Event Description

It was reported that patient underwent initial total right hip arthroplasty on approximately 9 years ago.Patient underwent revision procedure 9 years post initial implantation due to pain, limited range of motion, inflammation, and elevated metal ions.Attempts were made to obtain additional information; however, none was available.

• Brand Name: M2A TAPER 37/28MM LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; route #1 km 123.4 bldg #1; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9708244
• MDR Text Key: 179410631
• Report Number: 0001825034-2020-00705
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2000
• Device Model Number: N/A
• Device Catalogue Number: 15-105000
• Device Lot Number: 894270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Date Device Manufactured: 06/26/2000
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention