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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 28IDX50OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 10D 28IDX50OD; PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS Back to Search Results
Model Number 1218-28-750
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 02/22/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
It was reported that the patient was revised to a dual mobility for stability.Original implant date unknown.Doi: unknown; dor: (b)(6) 2021; left hip.
 
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Brand Name
PINN LNR CON +4 10D 28IDX50OD
Common Device Name
PINNACLE HIP SYSTEM : HIP CONSTRAINED ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11436073
Report Number1818910-2021-04576
Device Sequence Number4076328
Product Code KWZ
UDI-Device Identifier10603295011538
UDI-Public10603295011538
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K043058
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/22/2021
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 Model Number1218-28-750
Device Catalogue Number121828750
Device Lot NumberJ2132G
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/22/2021
Supplement Date Received by Manufacturer04/06/2021
Initial Report FDA Received Date03/08/2021
Supplement Report FDA Received Date04/09/2021
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 Age72 YR
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