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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX64OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 40IDX64OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Model Number 1221-40-164
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 08/23/2021
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
Pt lt total hip revised to prostalac spacer due to infection.Original left total hip (b)(6)2020.No other information available.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ALTRX +4 10D 40IDX64OD
Common Device Name
PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12469765
Report Number1818910-2021-20066
Device Sequence Number14421488
Product Code LPH
UDI-Device Identifier10603295393467
UDI-Public10603295393467
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K132959
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
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) 08/24/2021
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 Number1221-40-164
Device Catalogue Number122140164
Device Lot NumberJ39H16
Initial Date Received by Manufacturer 08/24/2021
Supplement Date Received by Manufacturer10/04/2021
Initial Report FDA Received Date09/14/2021
Supplement Report FDA Received Date10/04/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
12/14 ARTICUL 40MM M SPEC+5.; ALTRX +4 10D 40IDX64OD.; CORAIL2 LAT COXA VARA SIZE 16.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN MULTIHOLE W/GRIPTION 64MM.; 12/14 ARTICUL 40MM M SPEC+5; ALTRX +4 10D 40IDX64OD; CORAIL2 LAT COXA VARA SIZE 16; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MULTIHOLE W/GRIPTION 64MM
Outcome Attributed to Adverse Event Required Intervention;
Patient Age72 YR
Patient Weight81
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