MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-3 PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Material Erosion (1214); Separation Failure (2547)

Patient Problems Erosion (1750); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Reaction (2414); Blood Loss (2597)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: m2a-magnum mod hd sz 52mm, pn 157452, ln 101240, taperloc por fmrl 15x150, pn 103208, ln 301550, m2a-magnum pf cup 58odx52id, pn us157858, ln 722540. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00104, 0001825034-2020-00106, 0001825034-2020-00107. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient became infected and had the hip irrigated and debrided on an unknown date. The patient received antibiotics for 6 weeks. Then the patient was revised approximately one year later. Findings at the time of the revision were: stem was well positioned and fixed, acetabular shell was fixed, steep and overly and anteverted, head adapter was cold welded to the stem trunnion so large head was first separated from the adaptor so the taper adaptor can be removed. The articular surface of the head shows severe corrosion as well as high cobalt levels. Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Primary right tha was performed. Patient subsequently developed elevated metal ions and noise. Attempted revision procedure; however, surgical procedure was aborted and surgical site was irrigated and closed. Patient experienced a superficial infection. Approximately 3 months later, patient underwent revision procedure due to elevated metal ion levels, metallosis, corrosion and malposition of the acetabular component. During the procedure, estimated blood loss was 1600 ml. Attempts were made to obtain additional information; however, none was available.

• Brand Name: M2A-MAGNUM 52-60MM TPR INSRT-3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9569832
• MDR Text Key: 174532895
• Report Number: 0001825034-2020-00105
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 139266
• Device Lot Number: 068770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 01/09/2020 Patient Sequence Number: 1