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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-22-054
Device Problem Loss of Osseointegration (2408)
Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Pain (1994); Rash (2033); Seizures (2063); Tissue Damage (2104); Burning Sensation (2146); Cramp(s) (2193); Dizziness (2194); Hypoesthesia (2352); Depression (2361); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Event Date 12/18/2012
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
New unity record created in order to update etq complaint number (b)(4). New etq record created in order to update etq (legacy system) complaint number (b)(4). Reason for original complaint. - litigation papers allege: bilateral patient was implanted with depuy pinnacle hip implant in her left hip on (b)(6) 2006, and in her right hip on (b)(6) 2006. The patient's hips are defective and have caused damage to her hip joints and her body. Doi: (b)(6) 2006 - dor: unk (left side). Doi: (b)(6) 2006 - dor: unk (right side). Patient is a resident of (b)(6). Update: (b)(6) 2012 pfs was received from legal, medical records were received from legal, and part/lot information was identified by invoice search. Records are available for further review. Patient demographics added. Update ad (b)(6) 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets. In addition to what were previously alleged, ppf alleges metallosis, metal wear and elevated metal ions. Updated the date of implant and event date. Added date of revision, revision hospital, revision surgeon, law firm, lawyer and expiration dates to the head and liner products. Added cup, stem, apex hole eliminator and bone screws due to alleged elevated metal ions and they were removed in the ppf. Doi: (b)(6) 2006 - dor: (b)(6) 2012 (left hip). Please see (b)(4) for the right hip.
 
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Brand NamePINNACLE SECTOR II CUP 54MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9937839
MDR Text Key189651091
Report Number1818910-2020-10426
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,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-22-054
Device Catalogue Number121722054
Device Lot NumberAP2E61000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2006
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: 04/08/2020 Patient Sequence Number: 1
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