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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Anemia (1706); Atrial Fibrillation (1729); Unspecified Infection (1930); Memory Loss/Impairment (1958); Sleep Dysfunction (2517); Taste Disorder (4422); Metal Related Pathology (4530); Decreased Appetite (4569)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant product: unknown stem.Multiple reports were submitted along with this report 0001822565-2021-02490.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
 
Event Description
It was reported that the patient was revised due to elevated ion levels, joint infection and metallosis approximately 9 years post implantation.It was also noted that the patient suffered from loss of circadian rhythm, loss of deep sleep, complete loss of short-term memory, partial loss of long-term memory, loss of executive functions (organizing etc), hypersensitivity of taste (too sweet, too salty), loss of appetite.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
The initial was submitted under a wrong manufacturing site.This report should be voided, as it was submitted in error.An updated report will be submitted under the corrected manufacturing site mfr number (b)(4).
 
Manufacturer Narrative
The initial was submitted under a wrong manufacturing site.This report should be voided, as it was submitted in error.An updated report will be submitted under the corrected manufacturing site mfr number (b)(4).
 
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Brand Name
UNKNOWN HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key12436494
MDR Text Key270262868
Report Number0001822565-2021-02491
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/25/2021
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 Model NumberN/A
Device Catalogue NumberN/I
Device Lot NumberN/I
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/25/2021
Initial Date FDA Received09/07/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE.
Patient Outcome(s) Hospitalization; Required Intervention;
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