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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-058
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/28/2018
Event Type  Injury  
Manufacturer Narrative
(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
Initial information received alleged patient reported symptoms related to mom implants: pinnacle mom litigation record received. Litigation alleges injury, emotional trauma, distress, worsening pain and seized metal on metal with significant inflammatory reaction. Upon revision the stem and acetabular cup were rigidly attached, well fixed and not loose. Doi: (b)(6) 2011; dor: (b)(6) 2018 (left hip). Further information received 02/05/2021: update ad 05 feb 2021: (b)(4) has been re-opened due to pinnacle pfs and medical records received. Pfs alleges severe pain and suffering, limp and mobility issues. Plaintiff is seeking claim for all the damages. After review of the medical records the patient was revised to address pain with significant inflammatory reaction, sleep disturbance, cystic changes on the proximal femur. Radiograph reported acetabulum concerning for loosening. The morbid obesity causing longer incision and difficult manipulation. Operative note reported fairly extensive fluid collection in subcutaneous tissue with fat necrosis, significant cavitary defect on the proximal femoral stem, thinning of the core tracts and cavitary lesions behind the acetabulum, significant amount of inflammatory tissue that required extensive debridement as well as diffuse punctate bleeding secondary to the significant inflammatory tissue. Tissues and scar were debrided to expose acetabulum. The shell and stem are well fixed. Intra op there was a very small crack at end of the proximal femur adjacent to the end of the stem.
 
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Brand NamePINN SECTOR W/GRIPTION 58MM
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 dr
warsaw, IN 46581
6107428552
MDR Report Key11334455
MDR Text Key232319505
Report Number1818910-2021-03106
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
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 Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Model Number1217-32-058
Device Catalogue Number121732058
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2011
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: 02/16/2021 Patient Sequence Number: 1
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