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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/56 HIP PROSTHESIS

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ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/56 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Positioning Problem (3009); Insufficient Information (3190)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Information (3190)
Event Date 01/25/2017
Event Type  Injury  
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. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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. Concomitant medical products: item # unk, hip-mom-heads-unk, lot # unk, item # unk, hip-unknown-stems-unk, lot # unk. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-10142, 0001825034-2018-10143, 0001825034-2018-10144.
 
Event Description
It was reported that a patient was revised due to unknown reasons an unknown timeframe post implantation. Attempts have been made, and no further information has been provided.
 
Event Description
It was reported that a patient was revised approximately 12 years post implantation due to elevated ion levels, pain, corrosion, pseudotumor, malposition of cup, osteolysis and bone loss. Op notes indicated significant pain, elevated ion levels, and a pseudotumor. Other findings include: the cup is in an unacceptable angle, significant metal corrosion on the trunnion, upon removing the cup there was significant osteolysis and cavitary bone loss. Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
Concomitant medical products: item # 11-163667, m2a-magnum mod hd, lot # 042600, item # 15-105004, m2a-taper liner, lot # 809170, item # 11-103205, ntegral/xlat por, lot # 895150. An additional report has been submitted for this event: 0001825034-2018-11302.
 
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Brand NameM2A-T UNIV 2-HOLE SHL SZ 41/56
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8028124
MDR Text Key125782342
Report Number0001825034-2018-10143
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K003363
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 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2014
Device Model NumberN/A
Device Catalogue Number15-103686
Device Lot Number285850 
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/01/2018 Patient Sequence Number: 1
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