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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Degraded (1153); Malposition of Device (2616); Migration (4003)
Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hearing Impairment (1881); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Toxicity (2333); Hypoesthesia (2352); Test Result (2695); No Code Available (3191)
Event Date 01/30/2020
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's left hip was replaced by (b)(6) 2008. The operative report shows that this is a pinnacle 100 series, 50mm outer diameter titanium cup with a pinnacle metal insert, a size 3 standard offset summit tapered stem with a dual fixed ha coating, and a 36mm +1. 5 cobalt chrome femoral head. This placed via a direct lateral approach. The hip started to become painful laterally in (b)(6) of 2018 and in the groin in the spring of 2019, aggravated with activities. Pain x-rays of the hip show a well=positioned acetabular component which is osseointegrated with a 36 mm metal on metal bearing and a summit stem, which is in slight varus but the stem is well osseointegrated. A metal suppression mri of the left hip was obtained on (b)(6) 2018 showed some fluid in the joint and some fluid in the trochanteric bursal area. She also developed a notable tremor of the ulnar digits of both hands in 2018. She also noted in 2018 that she had poor balance and reduced pain tolerance. In 2016 she noticed short-term memory issues and poor mood and fatigue. In 2017, she noticed numbness and tingling of hands and feet. In 2018 she noticed tinnitus and deafness. In the same period of time, she had noticed difficulty with vision at night with flashing lights. On (b)(6) 2019, serum/plasma cobalt level was 4. 5 mcg/l. On (b)(6) 2020, blood cobalt level was 3. 9 mcg/l and her urine cobalt level was 5. 8 mcg/l. Her fdg pet brain scan analysis was notable for general and focal hypometabolism consistent with chronic toxic encephalopathy. Due to these compounding symptoms and rising cobalt levels, she elected to have the left hip revised on (b)(6) 2020. The stem was sound and was in 15 degrees of anteversion, the trunnion and head bored showed gross corrosion. There was no lysis about the femoral component. Posterior capsule was intact, anterior capsule was thickened with armd, abduction tendons were intact. Intraoperative frozen section showed no ai. Fluid from the left hip was collected and sent for cobalt level, and those results are still pending. The acetabular components was in 45 degrees of abduction and anteverted about 20 degrees. It was not loose and there was minor lysis. It was revised to allow for use of a 36 mm ceramic head. The depuy no hole 50 od socket, 36 mm id cobalt chrome liner and 36 mm +1. 5 cobalt chrome head were removed and replaced with depuy pinnacle multiple hole 52 od with 4 dome screws. Altrex neutral 36 id socket liner and a 36 mm +1. 5 mm length delta ceramic option head. Doi: (b)(6) 2008. Dor: (b)(6) 2020. Left hip.

 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
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 Key9823717
MDR Text Key196403335
Report Number1818910-2020-07572
Device Sequence Number1
Product Code KXA
Combination Product (Y/N)N
Reporter Country CodeUS
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,Followup
Report Date 02/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received06/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/12/2020 Patient Sequence Number: 1
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