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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. G7 HARD BEARING INST RING SZ C ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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BIOMET UK LTD. G7 HARD BEARING INST RING SZ C ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial report. Report source, foreign - event occurred in (b)(6). We have been informed by the customer that the product will not be returned to zimmer biomet for investigation. Associated product: medical product: g7 dual mobility liner 38mm c, catalog #: 110024461, lot #:638880. Once the investigation has been completed, a supplemental mdr will be submitted.
 
Event Description
It was reported that during impaction the inserter ring broke in two. Attempts have been made and no further information has been provided at this time.
 
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Brand NameG7 HARD BEARING INST RING SZ C
Type of DeviceORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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 Key11870171
MDR Text Key252167181
Report Number3002806535-2021-00222
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K150522
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 06/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110026852
Device Lot NumberUNKNOWN
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 Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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