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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 52MM; HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS, INC. 1818910 PINN SECTOR HA ACET CUP 52MM; HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121712052
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: following receipt of additional information the complaint was re-opened.It was noted that the complaint had previously been registered under (b)(4).A review of the information received identified no additional investigational inputs.No further investigation was required and no changes were required to the previous investigation conclusions.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient has increasing pain in right hip from mid-2009; two aspirations of fluid.Doi: (b)(6) 2007; dor: (b)(6) 2010; right hip.
 
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Brand Name
PINN SECTOR HA ACET CUP 52MM
Common Device Name
HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key7230295
Report Number1818910-2018-52418
Device Sequence Number13982480
Product Code LPH
UDI-Device Identifier10603295009160
UDI-Public10603295009160
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K031495
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2010
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number121712052
Device Lot NumberA5CF21000
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/12/2018
Initial Report FDA Received Date01/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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