MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136552000

Device Problem Naturally Worn (2988)

Patient Problems Pulmonary Embolism (1498); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Litigation alleges friction and wear between cobalt-chromium head and liner causing elevated metal ions and particles in plaintiff blood, tissue and bone resulting to inflammation, mental and emotional injuries, pain and discomfort when ambulating.Doi: (b)(6) 2010; dor: (b)(6) 2019; right hip.

Event Description

After review of medical records the patient was revised to address metallosis and polyethylene failure.Operative note reported bare bone on the femoral head and acetabulum with mark osteophytes on the acetabulum.Encountered a blackish synovial fluid, there was black tissue in the trochanteric bursa these were all remove.Synovium was blackened anteriorly.Superior fragment had fractured polyethene.Clinical visit reported pain, grinding with range of motion, depression, anxiety, sleep disorder and numbness.X-ray revealed had significant poly wear or possible fracture right hip.Alleged elevated metal ions however cobalt and chromium blood result shows below 7 ppb.In addition to what was previously reported in the medical records and after review the patient was revised to address grinding with any range of motion, numbness, depression, anxiety, sleep disorder, tenderness over the groin, limited range of motion.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a2 (age), b5, b6, d4, g2, g4, h4, h5.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d2b, d10, g1.

Manufacturer Narrative

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, post market surveillance, 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.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Pfs alleges tissue damage, deep venous thrombosis, pulmonary embolism, antiphospholipid syndrome, chronic anticoagulation therapy, at risk for multitude of issues, falls, economic loss, pain and suffering.Patient had continued pain, limited movement, metallosis and tissue damage.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The pfs mentions: tissue damage, deep venous thrombosis, pulmonary embolism, antiphospholipid syndrome, need for chronic anticoagulation therapy, at risk for a multitude of issues including falls, two secondary revision surgeries to replace the faulty devices, extensive rehabilitation, economic loss, pain and suffering that began in 2011.The pfs mentioned continued pain and unable to lift right leg due to pain and limitations in movement of right hip due to metallosis and tissue damage.On (b)(6) 2010, patient had a left hip arthroplasty to address degenerative joint disease.Depuy components were implanted during this procedure.The patient had a discharge diagnosis of acute blood loss anemia, status post left total hip arthroplasty.Depuy products were placed during this procedure.On (b)(6) 2010, the patient had a right hip arthroplasty to address degenerative joint disease.Depuy components were used during this procedure.(b)(6) 2019 medical records note patient is returning for follow-up for right hip.Patient has had severe groin pain.Medical condition includes: phlebitis, pulmonary embolism.*no mention of when the pulmonary embolism occurred.On (b)(6) 2019, the patient had a partial revision right hip, acetabular component with femoral head exchange to address polyethylene failure, metallosis of the right hip.The surgeon reported finding areas of bare bone on the femoral head and acetabulum with marked osteophytes on the acetabulum.During the procedure the surgeon observed blackish synovial fluid, black tissue.The liner was noted to be loose in the cup and had fractured.The cup and stem were not revised.Femoral head removed without allegation of deficiency.On (b)(6) 2020, the patient had a partial revision of left hip, including femoral head and acetabular polyethylene, to address polyethylene failure.Prior to surgery the patient experienced pain in the left hip along with a sensation of grinding.Radiographs are reported to show a fractured polyethylene liner.During the procedure the surgeon observed black fluid, black tissue.The liner was disassociated from the shell and the femoral head was rubbing against the anterior of the acetabular cup.The liner/head were revised, the cup and stem remained in-situ.Depuy components were used during this procedure.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : device associated with this report was not received for examination.All available x-rays were reviewed.No photos of the explanted femoral head were attached, worn condition cannot be observed on x-ray evidence.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records were received: on (b)(6) 2020 medical records note the patient is experiencing some numbness and tingling down the right leg, along with right groin pain and weakness.On (b)(6) 2021 medical records note patient has been having increased weakness of the iliopsoas muscle right hip, the patient is scheduled for an injection in the iliopsoasa muscle.On (b)(6) 2021 the patient had iliopsoas tendon injection under fluoroscopic guidance to address right hip pain, iliopsoas bursitis, tendonitis.It should be noted that these events happened after the (b)(6) 2019 right hip revision captured on (b)(4).

• Brand Name: ARTICULEZE M HEAD 36MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds IN LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11164562
• MDR Text Key: 226631833
• Report Number: 1818910-2021-00988
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/05/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: 136552000
• Device Lot Number: 3157448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/01/2021; 02/24/2021; 05/24/2022; 05/24/2022; 07/05/2022
• Supplement Dates FDA Received: 02/10/2021; 02/24/2021; 06/03/2022; 06/09/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: +4 POLYETHYLENE LINER; METAL FEMORAL HEAD 36MM; PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; SIZE 5 TRILOCK FEMORAL STEM; TRI-LOCK BPS SZ 5 STD OFFSET; +4 POLYETHYLENE LINER; METAL FEMORAL HEAD 36MM; SIZE 5 TRILOCK FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male