MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TAPER LINER 32MM I.D. SIZE 41 MM O.D. TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Reaction (2414)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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 - 04317.

Event Description

It was reported patient¿s hip was revised approximately 5 years post implantation due to pain and elevated metal ion levels.The cup and head were removed.The stem was retained.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: M2A TAPER LINER 32MM I.D. SIZE 41 MM O.D. TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7646439
• MDR Text Key: 112613536
• Report Number: 0001825034-2018-04315
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2012
• Device Model Number: N/A
• Device Catalogue Number: 15-105004
• Device Lot Number: 455320
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 10-104056 858140 M2A-T M/H RAD 2HL SHL 41/56MM; 11-163669 517410 32MM M2A MOD HEAD STD NK; 162255 243910 BI-METRIC POROUS FMRL 16X160MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR