MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problem Naturally Worn (2988)

Patient Problems Pulmonary Embolism (1498); Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Depression (2361); Numbness (2415); Ambulation Difficulties (2544); Fibrosis (3167); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/09/2020

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) 2020; left hip.

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.

Event Description

After review of medical records the patient was revised due to wear of articular bearing of internal prosthetic left hip joint.Clinical visit reported left hip pain, grinding sensation with pain in her groin, fatigue, tenderness over the groin, restricted range of motion, depression, anxiety, sleep disorder and numbness.Alleged elevated metal ions however cobalt and chromium blood result shows below 7 ppb.

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

Addition to what were reported in the medical records, after review the patient was revised to address fractured polyethelene, shortening of the leg, limited adl swelling and metallosis.Operative note reported subluxation of the femoral head, disassociated liner from the shell with spin out.Metal head had been rubbing on the titanium shell.There was copious amounts of black fluid erupted.The capsule had a small 1 cm defect.Black synovium in the iliopsoas tension sheath was debrided.Surgical pathology reported foreign body reaction, benign fibrous capsule with slight chronic inflammation and deposit of exogenous pigment adherent fibrin and anemia.X-ray reported polyethylene fracture.

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.

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).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.

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.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).Investigation summary: the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for device, it could be observed that acetabular cup and femoral head are having unintended interaction.It is most likely probable that poly liner and acetabular cup were disassociated.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.Corrected/re-captured: h6 (clinical code) appropriate term/code not available (e2402) has been replaced with depression (e020202).

Event Description

Additional information was received: there were no new allegations for the left hip.

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.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• 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): DEPUY INT'L LTD. 8010379; 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: 11164475
• MDR Text Key: 226627851
• Report Number: 1818910-2021-00985
• Device Sequence Number: 1
• Product Code: LPH
• 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: 05/31/2014
• Device Catalogue Number: 136553000
• Device Lot Number: 2921899
• 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: 01/15/2021; 02/01/2021; 02/26/2021; 05/24/2022; 12/14/2022; 01/17/2023
• Supplement Dates FDA Received: 01/18/2021; 02/10/2021; 02/28/2021; 06/08/2022; 12/15/2022; 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2009
• 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: PINN MAR +4 NEUT 36IDX52OD; PINNACLE 100 ACET CUP 52MM; TRI-LOCK BPS SZ 5 STD OFFSET; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male