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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX52OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-352
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Unspecified Tissue Injury (4559)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint #
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> (b)(4). A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided. Initial reporter occupation: lawyer. (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
The patient had metal on metal revision. Plastic liner and new head were implanted. No further information available. After review of the medical records the patient was revised to address failed right hip replacement with adverse metal reaction and placement of antibiotic beads. Revision note indicated that there was small murky fluid collection around the hip and some trunnion corrosion. There was no impingement noted. Laboratory findings showed elevated chromium and cobalt level. The unknown liner and head in the impacted product were updated and added the stem to capture the reported corrosion and elevated metal ions. Doi: unknown. Dor: (b)(6) 2019. Right hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX52OD
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 anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10465669
MDR Text Key204723162
Report Number1818910-2020-18982
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1218-87-352
Device Catalogue Number121887352
Device Lot Number1965164
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2005
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: 08/28/2020 Patient Sequence Number: 1
Treatment
ARTICULEZE M HEAD 36MM +8.5; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ5 STD OFF
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