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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN ANKLE TIBIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN ANKLE TIBIAL Back to Search Results
Catalog Number UNK ANKLE TIBIAL
Device Problem Disassembly (1168)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 05/07/2018
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Exchange of liner - mobility ankle + calcaneal osteotomy + internal brace: (b)(6) 2018. As per surgeon - liner loose, ankle joint showing osteolysis. No primary date known. No further details available via surgeon or patient notes. On removal the liner appeared worn on the lateral aspect as would be expected looking at the x-ray. Jnj representative was present at the case. Female patient (b)(6).
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). No device associated with this report was received for examination. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand NameUNKNOWN ANKLE TIBIAL
Type of DeviceANKLE TIBIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582-0988
5743725905
MDR Report Key7568926
MDR Text Key110062351
Report Number1818910-2018-61350
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeNZ
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 05/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK ANKLE TIBIAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/05/2018 Patient Sequence Number: 1
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