MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scar Tissue (2060); Dizziness (2194); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr resurfacing litigation records received.After review of records, the plaintiff alleges pain, loss of balance, difficulty in walking, upset stomach, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, dizziness, chronic fatigue, chronic pain, severe emotional and/or psychological distress relating to the pain and suffering and elevated metalions.Doi: (b)(6) 2009.Dor: none reported.Unknown affected side.

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Asr resurfacing litigation records received.After review of records, the plaintiff alleges pain, loss of balance, difficulty in walking, upset stomach, metallosis, tissue dehiscence, tissue necrosis, bone necrosis, hypertrophic scarring, antalgia, lumbar strain, dizziness, chronic fatigue, chronic pain, severe emotional and/or psychological distress relating to the pain and suffering and elevated metalions.Doi: (b)(6) 2009.Dor: none reported.Unknown affected side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Device history lot: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.

Manufacturer Narrative

Product complaint # 1818910-2022-03714-3 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

Update ad 14 may 2022 additional information received from aei note (b)(6).Pinnacle medical records received.After review of medical records patient alleges clunking sensation and elevated cobalt and chromium levels however laboratory results shows below normal level.No revision notes reported.Doi: (b)(6) 2009.Dor: unknown.Left hip.

Event Description

Medical records reported that patient experienced clunking sensations.On (b)(6) 2022, the patient was revised due to painful left metal on metal construct.Operative noted a large effusion and fluid was murky and greyish but not purulent.The proximal femur has significant osteolysis.Doi: on (b)(6) 2009; dor: on (b)(6) 2022; 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: added: a2 age, e1 facility name, h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 health effect - impact code.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13619012
• MDR Text Key: 286240059
• Report Number: 1818910-2022-03714
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 3004194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +1.5.; CORAIL2 NON COL HO SIZE 12.; PINN CAN BONE SCREW 6.5MMX30MM.; PINNACLE MTL INS NEUT36IDX54OD.; PINNACLE SECTOR II CUP 54MM.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR