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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS Back to Search Results
Catalog Number 121881754
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/07/2021
Event Type  Injury  
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 Description
It was reported that on (b)(6) 2016, the patient underwent the tha surgery with the cup.The surgery was completed successfully without any surgical delay.After the surgery, on (b)(6) 2021, the revision surgery will be performed due to infection.No further information is available.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Additional information received indicated that the stem and acetabular cup were not loose.It was unlikely that metallosis and osteolysis has occurred.The liner and stem were not revised only the cup.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Removed expiration date (1/31/2020) as there was no sticker sheet attached to this complaint.
 
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Brand Name
EA DELTA CER INSERT 36IDX54OD
Type of Device
PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12367703
MDR Text Key268144714
Report Number1818910-2021-18661
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 08/04/2021
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
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue Number121881754
Device Lot Number8074493
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received08/25/2021
Supplement Dates Manufacturer Received08/31/2021
09/10/2021
09/15/2021
Supplement Dates FDA Received09/03/2021
09/14/2021
09/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +8.5; EA DELTA CER INSERT 36IDX54OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN MULTIHOLE W/GRIPTION 54MM; SUMMIT POR TAPER SZ2 HI OFF; APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 36MM +8.5; EA DELTA CER INSERT 36IDX54OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN MULTIHOLE W/GRIPTION 54MM; SUMMIT POR TAPER SZ2 HI OFF
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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