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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN COBALT CHROME HEAD HIP PROTHESIS

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BIOMET UK LTD. UNKNOWN COBALT CHROME HEAD HIP PROTHESIS Back to Search Results
Model Number N/A
Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)
Event Date 01/24/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial report. Foreign report source: (b)(6). We are waiting to hear whether the product is available to be returned to zimmer biomet for investigation. Medical product: unknown magnum acetabulum cup , catalog: unknown, lot: unknown. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00546. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
The patient's legal counsel reported that the patient was implanted with an aura ii stem, a crco head and a magnum acetabulum on (b)(6) 2010. Following this total hip arthroplasty, the patient suffered from pain, however, he got back to professional life. On (b)(6) 2017, the patient fell and the prosthesis has decompensated. It was therefore seen through x-ray that the patient suffered from bipolar geodic reaction following a release of ions by the prothesis. Indeed, it was reported that the metal friction between the prothesis components has led to inflammatory granulomas with a phenomen of bone resorption. On (b)(6) 2020, the patient underwent a revision surgery to remove the prothesis. The delay observed between the fall on (b)(6) 2017 and the revision surgery can be explained by the implantation of a total hip prothesis on the left hip. This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
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Brand NameUNKNOWN COBALT CHROME HEAD
Type of DeviceHIP PROTHESIS
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 Key11027357
MDR Text Key222369908
Report Number3002806535-2020-00547
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN COBALT CHROME HEAD
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/27/2021
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 Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/17/2020 Patient Sequence Number: 1
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