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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. 32MM COCR BIOMET FEM HD +3 NK PROSTHESIS, HIP

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BIOMET UK LTD. 32MM COCR BIOMET FEM HD +3 NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 01/09/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). This product is manufactured by zimmer biomet us and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states under 510k number k042037. Concomitant medical products: 22-301343 arcos con sz c std 80mm ha 854650, 22-300918 arcos 18x190mm spl tpr dist ha 176110, unknown double mobility avantage cup, unknown double mobility avantage insert, 00625006515 bone screw self-tapping 6. 5 mm dia. 15 mm length 62566993, 00625006520 bone screw self-tapping 6. 5 mm dia. 20 mm length 62256199, 00625006520 bone screw self-tapping 6. 5 mm dia. 20 mm length 62748069 00625006540 bone screw self-tapping 6. 5 mm dia. 40 mm length 62440464, 11-302144 arcos lateral troch bolt 44mm 566380, 11-302102 arcos troch claw small 100mm 286710, 120002 cocr troch cable 2. 0mmx750mm 008130, 120010 cocr cable/sleeve set 2. 0mm 900490. The complaint cannot be confirmed since the surgical op notes were not provided. Post operative x-ray review shows the overall fit and alignment of the hardware is appropriate. Osteopenia is likely present. No signs of loosening or radiolucency. The device history records were reviewed and identified no deviations and/or anomalies that relate to the reported event. A definitive root cause cannot be established with the information provided. 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.
 
Event Description
It was reported that the patient underwent a right hip revision surgery. Subsequently, the patient experienced wound dehiscence. Patient was treated with debridement, cultures, and prophylactic antibiotics with in one month post implantation. No additional information is available.
 
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Brand Name32MM COCR BIOMET FEM HD +3 NK
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7855947
MDR Text Key119555689
Report Number3002806535-2018-01019
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number650-0873
Device Lot Number3123536
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 Received04/29/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2013
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: 09/07/2018 Patient Sequence Number: 1
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