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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN 28MM -6NECK TYPE 1 TAPER COBALT CHROME HEAD PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN 28MM -6NECK TYPE 1 TAPER COBALT CHROME HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Naturally Worn (2988)
Patient Problem Metal Related Pathology (4530)
Event Date 04/27/2022
Event Type  Injury  
Event Description
It was reported the patient underwent initial hip arthroplasty. Subsequently, the patient was revised approximately 23 years post implantation due to metal on metal wear and metallosis found on both acetabular component and femoral stem. Additional information on the reported event is unavailable.
 
Manufacturer Narrative
(b)(4). Concomitant products: unknown mallory acetabular cup 46mm; unknown mallory acetabular 10 degree liner size 22 for 28mm head; unknown taperloc stem. Report source: foreign country (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01000, 0001825034 - 2022 - 01001, 0001825034 - 2022 - 01003.
 
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Brand NameUNKNOWN 28MM -6NECK TYPE 1 TAPER COBALT CHROME HEAD
Type of DevicePROSTHESIS, 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 Key14269963
MDR Text Key290655962
Report Number0001825034-2022-01002
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received05/24/2022
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 Treatment Data
Date Received: 05/03/2022 Patient Sequence Number: 1
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