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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT40IDX58OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887458
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Pocket Erosion (2013)
Event Date 10/16/2010
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Initial reporter 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
After review of medical records patient was revised was due to septic right total hip had failed conservative treatment including lavage with component retention, loosening of the acetabular component. The plate itself had fractured and it was grossly loose with purulent fibrous tissue, some drainage present and had been overgrown by heterotopic bone. The acetabulum itself was eroded with several small areas of full-thickness penetration, necrotic debris was noted in the floor of the acetabulum. Doi: (b)(6), 2010, dor: (b)(6), 2010, right hip.
 
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Brand NamePINNACLE MTL INS NEUT40IDX58OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13769878
MDR Text Key287255231
Report Number1818910-2022-04699
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Followup
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/10/2012
Device Catalogue Number121887458
Device Lot Number2357866
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/15/2022 Patient Sequence Number: 1
Treatment
APEX HOLE ELIM POSITIVE STOP; ASPHERE M SPEC 12/14 40 +5; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 58MM; SUMMIT POR TAPER SZ8 STD OFF
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