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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-TAPER LINER SZ 41/32 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
Event Date 08/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 15-104096 ¿ m2a taper shell ¿ 099440. 11-163673 ¿ m2a head ¿ 452530. 11-112116 ¿impact distal ¿ 778100. 112085 ¿ metaphyseal - 423090. 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 - 2019 - 03037.
 
Event Description
It was reported that patient underwent a left hip revision approximately 16 years post implantation due to pain, discomfort, lack of mobility and elevated metal ion levels. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-TAPER LINER SZ 41/32
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 Key9243728
MDR Text Key166310172
Report Number0001825034-2019-04826
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2011
Device Model NumberN/A
Device Catalogue Number15-105004
Device Lot Number060920
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 Received10/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2001
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 10/28/2019 Patient Sequence Number: 1
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