MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 40MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-40-730

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

Patient Problems Fatigue (1849); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

After review of medical records, during the patient's right hip revision on (b)(6) 2018, the patient was reported to have elevated metal ion levels.It is known that while the patient was reported to have elevated metal ion levels, the patient had a ceramic head with a titanium sleeve currently implanted on his left hip along with a polyethylene liner.Doi: (b)(6) 2018; dor: no revision reported (left hip).Retained stem from previous revision is reported on (b)(4).

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 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.H10 additional narrative: product complaint #
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> (b)(4).Investigation summary
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> 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs alleges pain, discomfort, weakness in hips and legs, difficult adl, metal ions exposure and emotional distress.

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 symptom code: appropriate term/code not available (e2402) used to capture the pain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3, e3 (initial reporter occupation: lawyer) and h6 (impact code).

Manufacturer Narrative

Product complaint #
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> pc-(b)(4).Investigation summary
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> update 2/9/2023 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
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> 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.

• Brand Name: DLT TS CER HD 12/14 40MM +8.5
• 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
• 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: 9827779
• MDR Text Key: 183261821
• Report Number: 1818910-2020-07715
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033714
• UDI-Public: 10603295033714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073570
• 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
• Report Date: 02/20/2020

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: 1365-40-730
• Device Catalogue Number: 136540730
• Device Lot Number: 8398565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 04/14/2020; 11/10/2022; 02/09/2023
• Supplement Dates FDA Received: 04/15/2020; 11/30/2022; 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• 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: ALTRX +4 NEUT 40IDX58OD; CORAIL2 LAT COXA VARA SIZE 13; CUP 121730058/522893; DLT TS CER HD 12/14 40MM +8.5; HEAD 136540730/8398565; LINER 122140458/HK1532; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE BONE SCREW 40 MM; SCREW 121735500/D15123057; SCREW 121740500/C97KK4000; STEM 3L93713/2023024; CUP 121730058/522893; HEAD 136540730/8398565; LINER 122140458/HK1532; SCREW 121735500/D15123057; SCREW 121740500/C97KK4000; STEM 3L93713/2023024
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White