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

Model Number 1365-52-000

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Edema (1820); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Numbness (2415); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.Initial reporter occupation: lawyer.(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 there was metal on metal revision.Zimmer cup implanted with new head.After review of the medical records the patient was revised to address the failed left hip replacement and adverse metal reaction.Revision note reported of a large brown fluid collection and excessive combine anteversion with mild posterior femoral neck notching and mild taper corrosion.The acetabulum showed some ischial osteolysis.Mri reported of joint effusion with synovitis.Laboratory results for cobalt and chromium level showed above normal.The reported unknown cup, liner, and head from the ips were updated and added stem to capture the elevated metal ions and corrosion.The reported right side of the hip was changed to left side hip.Right hip was captured under (b)(4).Doi: unknown.Dor: (b)(6) 2019.Right 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.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).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: b1 (product problem), b5, h6 (clinical code).H6 clinical code: appropriate term / code not available (e2402) is used to capture bone injury (e20).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).E3: initial reporter occupation: lawyer.

Event Description

Patient alleges that a particulate debris from pinnacle devices causes severe inflammation, severe pain, tissue and bone loss and other related diseases.The known friction wear is believed to have caused amounts of toxic cobalt-chromium metal debris to be released into patient's tissue surrounding the implants.Mri had findings of adverse local tissue reaction.Patient alleges physical, mental, and emotional injuries.Patient experienced and will experience limited to partial or complete loss of mobility, loss of range of motion, mental anguish, and diminished enjoyment of life.Doi: on (b)(6) 2009, dor: on (b)(6) 2019, (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: h6 clinical code: appropriate term/ code not available (e2402) is used to capture blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture soft tissue injury and bone injury.Unspecified musculoskeletal problem (e1635) is used to capture joint injury and joint disorder.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Ppf alleges abductor muscle repair and pseudotumor.Revision notes stated posterior neck on rim impingement with minimal hip hyperextension and external rotation and decided to revise the cup.Cup, head, and liner were removed.Patient had left hip clicking and slipping.Patient experienced numbness in lower legs and feet due to metallosis, cannot lift feet when walking.During revision, the surgeon stated that there are more fluid and damage than expected.Patient fell in (b)(6) 2021 and had fractured femur due to difficulty in walking, and nerve pain is much morse at night when lay down.Fluid could reflect a small partial thickness tear, pseudocapsular thickening.Doi: (b)(6) 2009, dor: (b)(6) 2019, (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.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• 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): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10465560
• MDR Text Key: 204720050
• Report Number: 1818910-2020-18977
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033936
• UDI-Public: 10603295033936
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/05/2019

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: 07/31/2013
• Device Model Number: 1365-52-000
• Device Catalogue Number: 136552000
• Device Lot Number: 2688178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 05/26/2021; 04/21/2022; 02/08/2023
• Supplement Dates FDA Received: 09/04/2020; 06/14/2021; 05/06/2022; 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2008
• 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: PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ4 STD OFF; PINNACLE MTL INS NEUT36IDX52OD; PINNACLE SECTOR II CUP 52MM; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female