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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-050
Device Problems Loss of Osseointegration; Device Dislodged or Dislocated; Osseointegration Problem
Event Date 02/13/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

We have received an extrajudicial product liability claim on behalf of the patient (b)(6). The patient´s attorney claims that the patient was implanted with hip prosthesis pinnacle on (b)(6) 2017 in (b)(6) and that it was explanted on (b)(6) 2019. The letter claims that the patient has been home sick since then and under the care of (b)(6).

 
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Brand NamePINN SECTOR W/GRIPTION 50MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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
1210 ward avenue
west chester , PA 19380-0988
6107428552
MDR Report Key9734002
Report Number1818910-2020-05490
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-32-050
Device Catalogue Number121732050
Device LOT NumberHA4390
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/05/2017
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: 02/20/2020 Patient Sequence Number: 1
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