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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CPT STEM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN CPT STEM; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hip Fracture (2349)
Event Date 11/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 13 patients underwent an initial hip arthroplasty on an unknown date.Subsequently, the patients were revised due to periprosthetic fracture.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 under ( 0002648920-2020-00140).
 
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 under ( 0002648920-2020-00140).
 
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Brand Name
UNKNOWN CPT STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9401126
MDR Text Key168798605
Report Number0001822565-2019-05107
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/28/2020
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNK CPT HIP SYSTEM
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/15/2019
Initial Date FDA Received12/03/2019
Supplement Dates Manufacturer Received02/14/2020
Supplement Dates FDA Received02/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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