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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE 100 HA ACET CUP 58MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Catalog Number 121711058
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2013
Event Type  Malfunction  
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

Complaint description from etq: 1217-11-058 x1 pinnacle acetabular shell 100 series (lot: 311131) was implanted as per surgical technique. Subsequently, surgeon attempted to screw in (1246-03-000) apex hole eliminator (lot: d13033399) into acetabular shell. However, the apex hole eliminator could not screw into threads of acetabular shell. Therefore, a second apex hole eliminator (lot: d13050493) was opened. This too could not be implanted. The surgeon then said, although he had never had this issue in his multiple prior cases, the threads of the acetabular shell must have been burred. The surgeon decided to not worry about using a hole eliminator and subsequently implanted a shell liner, as per surgical technique. The operation was completed with no further problems.

 
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Brand NamePINNACLE 100 HA ACET CUP 58MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8746153
MDR Text Key173644850
Report Number1818910-2019-97197
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK031495
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121711058
Device LOT Number311131
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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