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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. RINGLOC-X E1 10DEG 52/32MM NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER

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BIOMET UK LTD. RINGLOC-X E1 10DEG 52/32MM NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Joint Dislocation (2374)
Event Date 11/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source, foreign - event occurred in (b)(6). The product has been returned to zimmer biomet for investigation. Medical product: cocr hd lng nk 32 +4mm 12/14, catalog #: p0206l32, lot #: j3729833; medical product: exc abt rnglc-x shell pc 052mm, catalog #: 131352, lot #: 3972375; medical product: unknown screw, catalog #: unknown screw, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00178. Occupation: patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent a total hip arthroplasty at the (b)(6) hospital, (b)(6). Subsequently, the patient has reported that a dislocation took place on (b)(6) 2018 where he was treated at the same hospital. A further dislocation took place and the patient was revised on (b)(6) 2018, again at the same hospital. No further information has been provided. This complaint reports the revision surgery performed on (b)(6) 2018.
 
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Brand NameRINGLOC-X E1 10DEG 52/32MM
Type of DeviceNON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
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 Key9863709
MDR Text Key190136106
Report Number3002806535-2020-00177
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberEP-063252
Device Lot Number6002209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/18/2017
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: 03/22/2020 Patient Sequence Number: 1
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