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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS TPRLC 133 TYPE1 PPS HO 14.0; PROSTHESIS, HIP

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BIOMET ORTHOPEDICS TPRLC 133 TYPE1 PPS HO 14.0; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component or Accessory Incompatibility (2897)
Patient Problem No Information (3190)
Event Date 03/04/2016
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".
 
Event Description
It was reported a patient underwent a left total hip arthroplasty on (b)(6) 2016.During the procedure, the stem was implanted and sat proud.The stem was removed and the surgeon rasped again.The stem was implanted and still sat proud.The stem was removed and a smaller stem was used to complete the procedure.This resulted in a 5-10 minute delay in procedure.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.Dimensional analysis found the device to be within specification; therefore, a conclusive root cause for the event could not be determined.
 
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Brand Name
TPRLC 133 TYPE1 PPS HO 14.0
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key5541673
MDR Text Key41668081
Report Number0001825034-2016-01095
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK101086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/08/2016
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 Physician
Device Model NumberN/A
Device Catalogue Number51-104140
Device Lot Number3612781
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2016
Initial Date FDA Received04/01/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2015
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age56 YR
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