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 Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Fatigue (1849); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 06/13/2022

Event Type  Injury  

Event Description

Pinnacle medical records received.After review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.Doi: (b)(6) 2020, dor: unrevised, affected side: left hip.

Manufacturer Narrative

Product complaint # (b)(4).Component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Updated event description: after review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.On (b)(6) 2020 cobalt 6.7 mcg/l chromium 34.6 mcg/l.On (b)(6) 2021 left hip mri noted a large fluid collection along with tears of the left gluteus medius and minimus tendon insertions.On (b)(6) 2021 lab results: chromium 24.3 ug/l.On (b)(6) 2022 radiographs of the left hip are reported to show the acetabular component is a little vertical in orientation.The patient noted that their hip feels unstable.It was noted that on (b)(6) 2022 the patient¿s hip dislocated and they needed a closed reduction.On (b)(6) 2022 lab values noted cobalt was 3.1 and chromium plasma was 33.5 with no unit of measurement provided.On (b)(6) 2022 the patient left total hip revision to address instability, pain, and abductor weakness left hip.Prior to surgery, the patient reported that they feel popping and had dislocated.During this procedure, the surgeon observed large joint effusion, metal debris as evidenced by black synovial tissue.The patient¿s abductor muscles were noted to significantly weakened with evidence of metal-on-metal debris.The acetabular cup, head, and liner were removed and depuy acetabular cup along with placement of dual mobility head, inner poly and ceramic head.On (b)(6) 2023 medical record notes a closed treatment of left femoral fracture, proximal end neck, with manipulation, post left hip arthroplasty dislocation.Closed avulsion fracture of lesser trochanter of left femur, closed dislocation of left hip.History of pain.One of the medical records noted that on (b)(6) 2023 radiographs note no evidence of acute fracture.(which is a contradiction of the reason for revision).

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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.E3 initial reporter occupation: lawyer.H6 clinical code: metal related pathology (e1618) is used to capture blood heavy metal increased and metal poisoning.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : pinnacle medical records received.After review of the medical records, clinical visit reported consistent mom disease , pain and limited adl, difficulty walking and muscle weakness after first revision of the left hip.Doi: (b)(6) 2020 ; dor: unrevised; left hip.The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The x-ray investigation revealed the articuleze m head 36mm +1.5 has dislocated from the hip joint and liner, it can be expected that due to the position of the head while dislocated that it might get damaged due to unintended contact against the cup or other surfaces.The provided evidence indicates that the intervention angle deviates from the stipulated surgical technique, where the cup appears to be positioned at angles greater than 45 degrees of abduction, additionally an increase in the degrees of anteversion is noted, which should ideally fall within the range of 15 to 30 degrees, as specified in the surgical technique.In comparison to the angles proposed by the surgical technique, page 18.This evidence, combined with the potential movements generated and the force exerted by the patient's weight, could lead to the reported allegation.Therefore, it is recommended to adhere to the surgical technique.One observation is that the femoral head appears not to be in the most appropriate position due to the implantation angle of the cup.A root cause cannot be definitively established.Please refer to pinnacle hip solutions surgical technique dsus/jrc/0414/0026 rev.3 joint instability can be confirmed with the evidence provided as the condition found on the device would have contributed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the [articuleze m head 36mm +1.5] would contribute to the complained device issue.  based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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 ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17208267
• MDR Text Key: 317921049
• Report Number: 1818910-2023-13090
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

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 Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 9400190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/06/2023; 03/28/2024
• Supplement Dates FDA Received: 07/06/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 36IDX58OD; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 58MM; SUMMIT POR TAPER SZ5 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White