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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: (b)(6).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.
 
Event Description
It was reported that during a hip arthroplasty, the screw head passed through the cup.Screw was removed.Attempts have been made and additional information on the reported event is unavailable at this time.No further information is available.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920-2019-00305.
 
Event Description
Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0002648920-2019-00305.
 
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Brand Name
BONE SCR 6.5X40 SELF-TAP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8420542
MDR Text Key138790837
Report Number0001822565-2019-01073
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00625006540
Device Lot Number64202382
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN ACETABULAR SHELL; UNKNOWN ACETABULAR SHELL
Patient Outcome(s) Hospitalization; Required Intervention;
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