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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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DEPUY ORTHOPAEDICS INC US 1818910 PINN MULTIHOLE W/GRIPTION 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121730050
Medical Device Problem Code Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189)
Date of Event 04/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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 was revised to address right hip pain.It was also indicated that aspiration was positive for infection, and loosening of the acetabular cup at the bone to implant interface.Doi: (b)(6) 2013; dor: (b)(6) 2018; right hip.No surgical delay.
 
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Brand Name
PINN MULTIHOLE W/GRIPTION 50MM
Common Device Name
PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key7544971
Report Number1818910-2018-60601
Device Sequence Number13960488
Product Code LPH
UDI-Device Identifier10603295009979
UDI-Public10603295009979
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K102423
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 04/27/2018
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 Number121730050
Device Lot Number326688
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/27/2018
Initial Report FDA Received Date05/25/2018
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 Age49 YR
Patient Weight84
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