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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX62OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT44IDX62OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887462
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994)
Event Date 12/01/2020
Event Type  Injury  
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
It was reported that the patient had a metal on metal construct.Revised due to corrosion on the head neck taper joint.Intraoperative findings identified metallosis in the inner aspect of the hip capsule and mild tissue scarring in the interval between the liner and the cup.Converted to a poly on ceramic construct.Lab results provided were below 7 ppb.Doi: (b)(6) 2007; dor: (b)(6) 2020; left hip.
 
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, post market surveillance, 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 complaint device manufacturing (dhr) reviews will not be performed.Per wi-3430 it has been determined that should related reports be identified a dhr review is not required.
 
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Brand Name
PINNACLE MTL INS NEUT44IDX62OD
Type of Device
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11343972
MDR Text Key232399107
Report Number1818910-2021-03267
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number121887462
Device Lot Number2374861
Was Device Available for Evaluation? No
Date Manufacturer Received04/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
12/14 ARTICUL 44MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT44IDX62OD; PINNACLE SECTOR II CUP 62MM; SUMMIT POR TAPER SZ9 HI OFF; 12/14 ARTICUL 44MM M SPEC+1.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE MTL INS NEUT44IDX62OD; PINNACLE SECTOR II CUP 62MM; SUMMIT POR TAPER SZ9 HI OFF
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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