• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Blood Loss (2597)
Event Date 02/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was confirmed by review of surgical notes. Patient underwent a revision due to significant pain. No infection noted. There was difficulty in breaking the cold weld attachment and separating the head from the trunnion. There was blood loss of 1200 ml without transfusion. Review of the device history records for reported components identified no deviations or anomalies that could contribute to the reported event. A definitive root cause cannot be determined with the information 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. (b)(4). Concomitant medical products: m2a-magnum taper sleeve # item 139268 lot 585000. Echo por fmrl nc stem # item 192012 lot 061550. M2a-magnum mod hd sz 52mm, item # 157452, lot 814460. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10113, 0001825034-2018-10114.
 
Event Description
It was reported that the patient underwent revision surgery approximately seven years post initial surgery due to significant pain and failed conservative measures. During the revision, it was noted there was abundant scar tissue requiring excision, and difficulty breaking the cold weld. Attempts have been made and additional information on the reported event is unavailable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM2A-MAGNUM PF CUP 58ODX52ID
Type of DevicePROSTHESIS, 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 Key8203016
MDR Text Key131620252
Report Number0001825034-2018-11550
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2020
Device Model NumberN/A
Device Catalogue NumberUS157858
Device Lot Number481240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2010
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
-
-