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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD STD NK; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A 38MM MOD HD STD NK; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Local Reaction (2035); Reaction (2414)
Event Date 02/12/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices: item #: unknown, unknown stem lot #: unknown; item #: unknown, unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product remains implanted.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 - 2020 - 03538.
 
Event Description
It was reported that the patient had right tha on an unknown date.The patient underwent a right hip revision due to metallosis, altr, implant wear, pain, instability, and implant malposition.No additional information is available.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.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.Medical records identified the following : the patient underwent a right total hip arthroplasty on an unknown date.The patient was revised due to failed hip arthroplasty.The patient had been suffering from pain.During the procedure, dark colored fluid, metallosis and capsular reaction with metal on metal debris was noted.The acetabulum was too far anteverted and unstable anteriorly.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.One m2a 38mm mod hd std nk item# 11-173662 lot# 405560 was returned and evaluated.Upon visual inspection the device had scratches on the flat near the taper location.There is black debris inside of the taper.If any further information is found which would change or alter any conclusions or information, a supplemental report 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 Name
M2A 38MM MOD HD STD NK
Type of Device
PROSTHESIS, 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 Key10545764
MDR Text Key207304262
Report Number0001825034-2020-03537
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2014
Device Model NumberN/A
Device Catalogue Number11-173662
Device Lot Number405560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/28/2020
Initial Date FDA Received09/17/2020
Supplement Dates Manufacturer Received09/29/2020
02/08/2022
03/17/2022
Supplement Dates FDA Received10/01/2020
02/16/2022
03/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2004
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10; SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight68 KG
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