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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 36IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1219-36-462
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Pain (1994); Joint Laxity (4526)
Date of Event 07/02/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported that patient had pain and instability.Doi: unk dor: (b)(6) 2021 left hip.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
PINN MAR +4 NEUT 36IDX62OD
Common Device Name
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12200630
Report Number1818910-2021-15570
Device Sequence Number4255336
Product Code LPH
UDI-Device Identifier10603295014751
UDI-Public10603295014751
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K010171
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/02/2021
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 Model Number1219-36-462
Device Catalogue Number121936462
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/02/2021
Supplement Date Received by Manufacturer08/13/2021
Initial Report FDA Received Date07/20/2021
Supplement Report FDA Received Date08/16/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MAR +4 NEUT 36IDX62OD; PINN SECTOR W/GRIPTION 62MM; ARTICULEZE M HEAD 36MM +1.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MAR +4 NEUT 36IDX62OD; PINN SECTOR W/GRIPTION 62MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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