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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD METAL ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD METAL ACETABULAR LINER Back to Search Results
Model Number 1218-87-362
Device Problems Degraded (1153); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 07/20/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Initial reporter occupation: lawyer. (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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pinnacle metal on metal claim letter received. Claim letter alleges pain, discomfort, difficulty walking and elevated metal ions. Mri suggested bilateral foreign body reaction with osteolysis and pseudotumor formation. Patient also suffered the following injuries but are not limited to metallosis, permanent tissue, muscle loss, limited adl and work, medical expenses, psychological and emotional injuries. Patient is seeking compensation for all the damages that have cause him. This is also serve as formal notice of claim and written demand. Doi: (b)(6) 2006; dor: unknown; right hip.
 
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Brand NamePINNACLE MTL INS NEUT36IDX62OD
Type of DeviceMETAL ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key12418132
MDR Text Key270837808
Report Number1818910-2021-19262
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2011
Device Model Number1218-87-362
Device Catalogue Number121887362
Device Lot Number2048439
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/02/2021 Patient Sequence Number: 1
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