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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)
Date of Event 10/10/2012
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint was re-opened (previously (b)(4)) following receipt of additional information.A review of the information 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
Persistent hip pain.(b)(6) 2006; (b)(6) 2012; 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 Key7230417
Report Number1818910-2018-52438
Device Sequence Number13765623
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 Year2006
Device Explanted Year2012
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 NumberA1PEP1000
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;
Patient Age77 YR
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