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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 28MM M2A MOD HEAD STD NK PROSTHESIS, HIP

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ZIMMER BIOMET, INC. 28MM M2A MOD HEAD STD NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Reaction (2414)
Event Date 02/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device is unknown. 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 - 2019 - 01307.
 
Event Description
It was reported that a patient underwent hip revision approximately 18 years post implantation due to high elevated ion metals and multiple pseudo tumors. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. Review of the available records identified the following: right hip demonstrates a right total hip arthroplasty with cement fixation of the acetabular cup. No radiolucency along the acetabular cup. Rounded lucency along the greater trochanter could suggest osteolysis or postsurgical change. Heterotopic ossification along the lateral acetabulum. Review of the device history record(s) identified no deviations or anomalies during manufacturing. A definitive root cause cannot 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name28MM M2A MOD HEAD STD NK
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8441388
MDR Text Key139538274
Report Number0001825034-2019-01306
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
PMA/PMN Number
K993438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2011
Device Model NumberN/A
Device Catalogue Number11-163662
Device Lot Number057200
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/21/2019 Patient Sequence Number: 1
Treatment
BIOMET M2A CUP CATALOG#15-104054 LOT#012090; BIOMET M2A LINER CATALOG#15-105000 LOT#171360; BIOMET PLUG CATALOG#135300 LOT#008110; BIOMET STEM CATALOG#180006 LOT#000610
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