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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN EXCEED ABT CERAMIC LINER UNKNOWN HIP ARTHROPLASTY

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BIOMET UK LTD. UNKNOWN EXCEED ABT CERAMIC LINER UNKNOWN HIP ARTHROPLASTY Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Patient Problem Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial report. Report source, foreign - event occurred in (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. Concomitant medical devices: medical product: unknown ceramic head, catalog #: unknown, lot #: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00480. Postal code: (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product remains implanted.
 
Event Description
Information received based on review of a journal article, entitled independent assessment and outcomes of 196 short-tapered stems short-term follow-up and review of the literature by sam nahas, akash patel, nicola blucher and vikas vedi et al. (2018). A journal article was retrieved from the journal of orthopaedic surgery (2018) that reported a retrospective single case series from the united kingdom that looked at assessment and outcomes of short-tapered stems. The purpose of the study was to assess the primary and secondary outcome of cementless microplasty taperloc stems. The study reviewed one hundred ninety-seven total hip arthroplasties (tha). One hundred five were males and ninety-one were females. All patients underwent implantation by a single consultant orthopaedic surgeon utilizing the microplasty taperloc stem in combination with the biomet exceed abt cup system all patients receiving a ceramic on ceramic bearing via the posterior approach. The study population had a mean age of 59 years at time of surgery (range 21-78). Follow-up was conducted at 6 six weeks, twelve months, and annually thereafter with a mean length of follow-up for 36 months (range 5-75). The study reported one patient who experienced a dislocation two years post-operatively and was treated with closed reduction.
 
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Brand NameUNKNOWN EXCEED ABT CERAMIC LINER
Type of DeviceUNKNOWN HIP ARTHROPLASTY
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 Key10851923
MDR Text Key216852362
Report Number3002806535-2020-00479
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/17/2020 Patient Sequence Number: 1
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