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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US +4 DRLC TRL LINER 28MM X 48MM HIP INSTRUMENTS : ACETABULAR TRIALS

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DEPUY ORTHOPAEDICS INC US +4 DRLC TRL LINER 28MM X 48MM HIP INSTRUMENTS : ACETABULAR TRIALS Back to Search Results
Model Number 2248-08-000
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Trial liner was noticeably damaged during reprocessing. No impact to case or patient.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: examination of the returned instrument confirmed the complaint. Depuy-synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name+4 DRLC TRL LINER 28MM X 48MM
Type of DeviceHIP INSTRUMENTS : ACETABULAR TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9771531
MDR Text Key184758175
Report Number1818910-2020-06442
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2248-08-000
Device Catalogue Number224808000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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