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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPRESS FINN TRANSVERSE PIN SIZE 48MM PROSTHESIS, HIP

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BIOMET ORTHOPEDICS COMPRESS FINN TRANSVERSE PIN SIZE 48MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 01/23/2017
Event Type  Injury  
Manufacturer Narrative
Medical product- compress 5cm taper adapter catalog#178711 lot# ni, compress oss locking cap and screw catalog# 178710 lot# ni, compress ha anti-rotation spindle small 38mm 800lbf porous coat catalog# 178355 lot# ni, compress segmental anchor plug 14mm catalog# 178404 lot# ni, compress finn nut catalog# 178512 lot# ni, compress finn transverse pin size 36mm catalog# 178528 lot# ni, compress transverse pin ti 40m m catalog# 178529 lot# ni, compress finn transverse pin size 48mm catalog# 178531 lot# ni, compress short anchor plug 10mm catalog# 178552 lot# ni, cps short anchor plug 14mm catalog# 178556 lot# ni. This report is number 6 of 10 mdrs filed for the same patient (reference 0001825034 - 2017 - 00779 , 0001825034 - 2017 - 00782, 0001825034 - 2017 - 00791, 0001825034 - 2017 - 00794, 0001825034 - 2017 - 00795, 0001825034 - 2017 - 00797, 0001825034 - 2017 - 00802, 0001825034 - 2017 - 00803, 0001825034 - 2017 - 00804, 0001825034 - 2017 - 00868).
 
Event Description
It was reported that items were missing in the implant sets and the case had to be cancelled. The patient had an epidural in when it was noticed that the components were missing.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. Dhr review was unable to be performed as the lot number of the device involved in the event is unknown. A process review revealed that the appropriate contents were included in the kit and procedure was followed by the manufacturer in communicating said contents to the distributorship; however, the kit documentation completed by the distributorship on the outside of the container did not indicate accurate contents. Review of complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was due to a labeling problem by the distributorship. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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Brand NameCOMPRESS FINN TRANSVERSE PIN SIZE 48MM
Type of DevicePROSTHESIS, 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
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6350104
MDR Text Key68046849
Report Number0001825034-2017-00797
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK043547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number178531
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2017
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: 02/22/2017 Patient Sequence Number: 1
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