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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Model Number 1218-87-362
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
Event Date 10/09/2020
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 this patient had his right hip replaced in 2004 at one of the (b)(6) medical center facility by dr. (b)(6). The patient was seen by dr. (b)(6). For right hip pain and discomfort some time ago and was being monitored by dr. (b)(6). For elevated ions due to a metal on metal articulation. This patient¿s hip was aspirated numerous times and dr. (b)(6). Stated the fluid was cloudy and dark color. Dr. (b)(6) assumed it was most likely metal wear particulate in the patients fluid. The patient and dr. (b)(6). Made the decision to revise the patients hip construct and explant the metal liner and metal head and implant a poly liner and a titanium sleeve ceramic femoral hip ball. The summit stem and 62mm pinnacle cup were left in situ. I do not have lot # information to share with you on the stem and cup that were originally implanted. Original implant date unknown. Doi: 2014. Dor: (b)(6) 2020 affected side: right hip.

 
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Brand NamePINNACLE MTL INS NEUT36IDX62OD
Type of DevicePINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st. anthony's rd
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10726780
MDR Text Key212734452
Report Number1818910-2020-23202
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062426
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1218-87-362
Device Catalogue Number121887362
Device LOT Number1098343
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 Received11/30/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/25/2003
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: 10/23/2020 Patient Sequence Number: 1
Treatment
62MM PINNACLE CUP; ARTICULEZE M HEAD 36MM +5; PINNACLE MTL INS NEUT36IDX62OD; SUMMIT STEM
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