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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A TAPER; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN M2A TAPER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problems Failure of Implant (1924); Scar Tissue (2060); Metal Related Pathology (4530)
Event Date 03/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location 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 - 2022 - 00383, 0001825034 - 2022 - 00384, 0001825034 - 2022 - 00387.
 
Event Description
It was reported that patient underwent a right hip revision approximately 13 years post implantation due to metallosis, altr, loosening of the cup, and scar tissue.During the surgery, black synovial tissue and corrosion on the trunnion were noted.The head, cup and taper were removed and replaced.The stem was left intact.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location 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 - 2022 - 00383, 0001825034 - 2022 - 00384, 0001825034 - 2022 - 00387.
 
Event Description
It was reported that patient underwent a right hip revision approximately 13 years post implantation due to metallosis, altr, loosening of the cup, and scar tissue.During the surgery, black synovial tissue and corrosion on the trunnion were noted.The head, cup and taper were removed and replaced.The stem was left intact.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Medical records were reviewed and notes that the patient underwent a revision for metallosis, altr, loosening, scar tissue and corrosion.Aseptic loosening of the cup is noted along with scar tissue, black synovial tissue consistent with metallosis.Trunnion shows minimal corrosion.Dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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.
 
Event Description
No additional event information to report at this time.
 
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Brand Name
UNKNOWN M2A TAPER
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 Key13584693
MDR Text Key286043421
Report Number0001825034-2022-00386
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient SexMale
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