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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON LNR PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A TPR HI CARBON LNR PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Pain (1994); Loss of Range of Motion (2032); Reaction (2414)
Event Date 04/19/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: x11-180312, bi-metric/x por nc lat 12x140, 774930; 15-103684, m2a-t univ 2-hole shl sz 41/54, 801490; 11-163688, 32mm m2a hi carbon hd std nk, 767120. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04295; 0001825034 - 2018 - 04297; 0001825034 - 2018 - 04298. Product location unknown.
 
Event Description
It was reported by the patient's legal counsel that the patient underwent left total hip arthroplasty. Subsequently, the patient underwent a revision procedure due to elevated ion levels. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined. 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.
 
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Brand NameM2A TPR HI CARBON LNR
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7647968
MDR Text Key112700687
Report Number0001825034-2018-04296
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
PK003363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup
Report Date 08/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Model NumberN/A
Device Catalogue Number15-105044
Device Lot Number912570
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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