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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINNACLE 300 ACET CUP 52MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-03-052
Device Problems Fracture; Malposition of Device; Device Dislodged or Dislocated
Event Date 05/11/2020
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 the patient had a failed pinnacle liner. The cup was poorly positioned and the superior aspect of the poly broke. The head then articulated with the shell and wore much of the titanium on the shell away. We removed the head, liner and shell and replaced with new implants. Doi: 6 years ago. Dor: (b)(6) 2020; right hip.

 
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Brand NamePINNACLE 300 ACET CUP 52MM
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key10088537
Report Number1818910-2020-12581
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1217-03-052
Device Catalogue Number121703052
Device LOT Number467714
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 Received07/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/07/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/26/2020 Patient Sequence Number: 1
Treatment
ALTRX +4 10D 36IDX52OD
ARTICULEZE M HEAD 36MM +12
PINNACLE 300 ACET CUP 52MM
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