MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +12; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hearing Impairment (1881); Pain (1994); Tinnitus (2103); Cognitive Changes (2551); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/01/2008

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

This patient has two hip devices,but this report is on the left hip on 2007.He underwent a left total hip arthroplasty by dr in.This is a depuy pinnacle metal on metal hip with 36 mm + 5 chrome cobalt head.The left hip had been bothering him since 2008.He described a sharp groin pain,especially with activity.He previously underwent a right tha with depuy duraloc socket and ceramic head on 2007,this right hip was revised to a pinnacle metal on metal articulation with a 40 mm + 8.5 chrome cobalt head.Indicated due to severe polyethylene were and it was performed by dr.As well on 2017.He had bilateral pinnacle metal on metal hips and his blood cobalt level was 6.3 mcg.He experienced increasing pain at the right hip and groin area associated with increasing metal levels and adverse reaction to metallic debris, so he reacted to have the right hip revised again on 2017.He underwent a second revision of his right total hiparthroplasty performed by dr.At medical center.The right hip was revised from the pinnacle metal on metal articulation to a stryker restoration acetabular wedge augment shell (ras) with a 36 mm internal liner and a + 12 ceramic head with a titanium sleeve on th existing stem dr.Noted significant adverse reaction to metallic debris.The patient has had four anterior dislocations of the right hip since the revision.The instability of his right tha likely due to the loss of periprosthetic tissue from reaction to metallic debris became his main problem.All while he still had a pinnacle metal on metal articulation on the left side and his systemic cobalt levels remained elevated on 2018.A urine cobalt level was 4.4 mcg/l on 2018.A blood cobalt level was 5.2 mcg/l and urine cobalt level was 9.4.On 2019 urine cobalt level was 23.0 mcg/l and blood cobalt was 5.3 mcg/l on 2019 blood cobalt level was 3.2 mcg/l and urine cobalt level at 16.3 mcg/l.His bilateral pinnacle metal on metal arthroplasties were implanted in 2007.As noted in the history he states that in of 2008, he began developing tremor in the hands and dulled dexterity,poor balance,forgetfulness,increased profound deafness and ringing in the ears.And he states this has been progressive.He complains of very loud ringing in his ears.He wears reading glasses since 2008.He has noticed twinkling flashes in the superior bi temporal visual field, which occurs about three to four times a month then family noted that he didn't seem as sharp as he once was.He also progressively developed fatigue since his hip replacement in 2007.He had been taking norco for pain on a semi regular basis.He was a mechanic but states he can no longer do manual work due to hand tremor and dulled dexterity, which he states is frustrating.He has numbness and tingling in the hands that began in 2006 or 2007.Neuro analysis of his fdg brain scan study made on 2019 showed general and focal hypometabolism in a pattern consistent with chronic toxic encephalopathy.Doi: 2017.Dor: 2017.Righ hip.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.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.

• Brand Name: DLT TS CER HD 12/14 36MM +12
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9788021
• MDR Text Key: 190125275
• Report Number: 1818910-2020-06848
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033684
• UDI-Public: 10603295033684
• Combination Product (y/n): N
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1365-36-740
• Device Catalogue Number: 136536740
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR STRYKER LINER; DLT TS CER HD 12/14 36MM +12
• Patient Outcome(s): Required Intervention