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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. M2A-MAGNUM RECAP CUP 54ODX48ID M2A MAGNUM RECAP CUP LG DIAM

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BIOMET UK LTD. M2A-MAGNUM RECAP CUP 54ODX48ID M2A MAGNUM RECAP CUP LG DIAM Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information. Item and lot numbers have been received. Design control is now the (b)(4). Event to be reported under (b)(4). Event was previously reported (initial and final) by (b)(4). The following sections were updated: additional information received: product item and lot numbers: desc: m2a-magnum recap cup 54odx48id. Item: 157854. Lot: 1944139. Desc: m2a-magnum mod hd sz 48mm. Item: 157448. Lot: 1789627. Associated products: medical product: taperloc bmpc 11. 0x142mm. Catalog no. : 650-0554bm. Lot no. : 1901177. Medical product: magnum tpr adpr ti 42-50/- 2mm. Catalog no. : 130829. Lot no. : 1905275. Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2022-00002. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported patient is experiencing elevated metal ion levels approximately 10 years post implantation. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-MAGNUM RECAP CUP 54ODX48ID
Type of DeviceM2A MAGNUM RECAP CUP LG DIAM
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 Key13152648
MDR Text Key284180951
Report Number3002806535-2022-00001
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/20/2020
Device Model NumberN/A
Device Catalogue Number157854
Device Lot Number1944139
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/26/2010
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: 01/04/2022 Patient Sequence Number: 1
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