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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS Back to Search Results
Catalog Number 121887350
Device Problems Corroded (1131); Difficult to Remove (1528)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Tissue Damage (2104); Weakness (2145); Test Result (2695); No Code Available (3191)
Event Date 01/28/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. (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

Unf and medical records received. There were no allegation reported from unf. After review of medical records, patient was revised to address right hip adverse local tissue reaction due to metal on metal total hip replacement. Indication note reported weakness, cobalt level 140 and chromium level 100, and on x-ray there was protrusion of the shell. Operative note reported significant amount of necrotic tissue that had corrosion, abductor tissue loss, and there was corrosion on the taper, corrosion at the edge of the shell and liner, and the liner appeared cold welded to the shell, bone loss from the shell removal, pseudotumor and cysts. Doi: (b)(6) 2008; dor: (b)(6) 2019; (right hip) first revision.

 
Manufacturer Narrative

Product complaint # (b)(4). Duplicate event found in mfr# 1818910-2019-84882. Additional information previously reported in 1818910-2019-84882 is being incorporated in this report. 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 dr texted the sales rep and said "i have a metal on metal revision hip coming up i wanted to see what my headliner options were". After a brief phone call, the surgeon decided that he was going to try to preserve the cup, remove the metal liner and preoperative plan was to trial and replace liner with +4/10° and +9 32mm head. Dr. Could not remove metal liner using a ab extractor, reciprocating saw, and bone tamps. Dr. Decided to remove entire cut implant zimmer acetabular cup and liner and also implant +5 ts 32 mm head. Nothing was said about the metal on metal liner but there was an obvious understanding that it was an issue based on the explant and tissue surrounding the cup. There was a surgical delay of 1 hour and 30 mins. Doi: (b)(6) 2008; dor: (b)(6) 2019'; right hip.

 
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Brand NamePINNACLE MTL INS NEUT36IDX50OD
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 anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9636450
MDR Text Key177027400
Report Number1818910-2020-03156
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 OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/28/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2012
Device Catalogue Number121887350
Device LOT Number2493590
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/20/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/28/2020 Patient Sequence Number: 1
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