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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR NEUT 28IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS, INC. 1818910 PINN MAR NEUT 28IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 121928054
Medical Device Problem Code Disassembly (1168)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event 03/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient was revised to address liner disassociation.It was also indicated that there was no report of harm.54 od 28 id poly liner and 28 +0 s-rom metal head were removed.Doi: unknown; dor: (b)(6) 2018; unknown hip.
 
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Brand Name
PINN MAR NEUT 28IDX54OD
Common Device Name
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7458940
Report Number1818910-2018-58253
Device Sequence Number13781576
Product Code LPH
UDI-Device Identifier10603295013310
UDI-Public10603295013310
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K001534
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number121928054
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/28/2018
Initial Report FDA Received Date04/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age60 YR
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