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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. RINGLOC-X E1 H/W 54/32MM 24 PROSTHESIS, HIP

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BIOMET UK LTD. RINGLOC-X E1 H/W 54/32MM 24 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 09/15/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr's were submitted for this event. Please see reports: 0001825034 - 2017 - 11151, 0001825034 - 2017 - 11152, 0001825034 - 2017 - 11153, 0001825034 - 2017 - 11154, 0001825034 - 2017 - 11155, 0001825034 - 2017 - 11156. (b)(4). Report source: foreign - the event occurred in (b)(6). Device remains implanted.
 
Event Description
It was reported the patient was prescribed antibiotics for 11 days to address wound drainage post-primary hip replacement. The outcome was considered resolved. No further information has been made available.
 
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed due to limited information received from customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.
 
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Brand NameRINGLOC-X E1 H/W 54/32MM 24
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 Key7282688
MDR Text Key100441824
Report Number3002806535-2018-00365
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue NumberEP-053254
Device Lot Number3276013
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/20/2018 Patient Sequence Number: 1
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