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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. TPRLC 133 MP TYPE1 PPS HO 15.0; PROSTHESIS, HIP
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BIOMET UK LTD. TPRLC 133 MP TYPE1 PPS HO 15.0; PROSTHESIS, HIP Back to Search Results
Catalog Number 51-107150
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the device had both inner and outer carton damage that was identified prior to use in the warehouse.No patient or surgical involvement.No further information is available at this time.
 
Event Description
It was determined this report was submitted under the incorrect manufacturer number.Please refer to 0001825034 - 2020 - 00260 for future communications.
 
Manufacturer Narrative
It was determined this report was submitted under the incorrect manufacturer number.Please refer to 0001825034 - 2020 - 00260 for future communications.
 
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Brand Name
TPRLC 133 MP TYPE1 PPS HO 15.0
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8678228
MDR Text Key147312630
Report Number3002806535-2019-00492
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K110400
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number51-107150
Device Lot Number3821950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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