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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM DIA TI MOD HEAD ION STD NK PROSTHESIS, HIP

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BIOMET ORTHOPEDICS 28MM DIA TI MOD HEAD ION STD NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 07/11/2017
Event Type  Injury  
Manufacturer Narrative
The information provided on this form was previously submitted under manufacturing report number 0001825034-2017-03387.
 
Manufacturer Narrative
(b)(4). Concomitant product(s): 104302 704990 acet lnr h-wall 28mm id sz b. 103507 564860 ti acet screw 5. 0x40mm. 103511 655230 ti acet screw 6. 5 x 25mm. 103507 635090 ti acet screw 5. 0x40mm. 103512 546610 ti acet screw 6. 5 x 30mm. 103554 664250 univ hexlc shl 54mm b. 162313 582950 bi-metric pc 13x145mm t1. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2017 - 06190.
 
Event Description
It was reported patient¿s hip was revised approximately 29 year post-implantation due to instability dislocation. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand Name28MM DIA TI MOD HEAD ION STD NK
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 Key6778094
MDR Text Key119231667
Report Number0001825034-2017-06197
Device Sequence Number1
Product Code LZY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK915548
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 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number163145
Device Lot Number608560
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 Received12/22/2017
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: 08/09/2017 Patient Sequence Number: 1
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