MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TAPER UNIVERSAL ALTERNATE BEARING SHELL; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 02/13/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown, unknown stem, unknown, unknown, unknown head, unknown, unknown, unknown liner, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 08065, 0001825034 - 2017 - 08064, 0001825034 - 2017 - 08067.Remains implanted.

Event Description

It was reported patient developed an infection ten days post implantation.Patient required long-term iv antibiotic therapy.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

Concomitant medical products: m2a modular head component, catalog #: 11-163670, lot#: 180950, collarless bi-metric porous stem, catalog#: x11-180314, lot#: 166690, m2a taper liner, catalog#: 15-105004, lot#: 876740, low profile self-tapping bone screw, catalog#: 103537, lot#: 998530.Reported event was confirmed by review of operative notes.Op notes dated nine days post-implantation states that the patient was found to have a low-grade fever and a wound infection.There were two small superficial skin openings with a small amount of serosanguinous drainage.The entire wound was painful, firm and had a erythematous base.Lab showed a white count of 10.9, sed rate was elevated to 39.X-ray showed the hardware in place.No loosening and no gas in the soft tissues.The patient had a central line placement 18 days post-implantation to maintain peripheral ivs.The patient was discharged 24 days after diagnosis of infection.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.

Event Description

It was reported patient developed an infection nine days post implantation.Patient required long-term iv antibiotic therapy including central line placement.Attempts to obtain additional information have been made; however, no more is available.

• Brand Name: M2A TAPER UNIVERSAL ALTERNATE BEARING SHELL
• 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: 6935033
• MDR Text Key: 89142714
• Report Number: 0001825034-2017-08066
• 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: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 15-103684
• Device Lot Number: 923020
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2001
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 112