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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 48MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

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DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 48MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS Back to Search Results
Model Number 1217-32-048
Device Problem Noise, Audible (3273)
Patient Problems Pain (1994); Loss of Range of Motion (2032)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was reported that: "i've operated a (b)(6) physiotherapist (healthy and thin) about 15 months ago. I've used a anterolateral approach. During the operation there was a small crack that i fixed with a cable without any practical effect. I used j&j pinnacle gription and corail stem with ceramic head and altrx liner. She healed very well and had normal and active life without any complaints. Two days ago, while sitting she felt a sudden pain at here left buttock (without any trauma) and as she started to try walking-she heard squawking. I saw her today and heard the noise myself and found some limited rom in the hip. On xray i think that the poly is broken and the head is fine. I will have to revise here soon. ".
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: no device associated with this report was received for examination. Review of the x-rays provided of the pinn sector w/gription 48mm could confirm a disassociation event. It is reasonable that noise would be present due to the ceramic head articulating against the metal cup. It is subsequent to the liner disassociation and does not signify any product error. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NamePINN SECTOR W/GRIPTION 48MM
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 IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13391833
MDR Text Key284679645
Report Number1818910-2022-01892
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K093646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1217-32-048
Device Catalogue Number121732048
Device Lot Number9457723
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2020
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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