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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Edema (1820); 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

(b)(4).Us fda device mdr decision completed.The products are reported due to progressive aphasia.(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.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 had bilateral pinnacle metal on metal hips and his blood cobalt level was 6.3 mcg.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.In 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 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.Has 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: 2007 tha; doe: 2008; left hip.

Manufacturer Narrative

Product complaint # (b)(4).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 has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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.  no code available (3191) was used to capture elevated metal ions.

Event Description

It was reported in medical records ad (b)(6) 2020 that patient suffered from effusion and elevated metal ions.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy 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: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9802191
• MDR Text Key: 189433119
• Report Number: 1818910-2020-07147
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; UNKNOWN ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention