MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532320

Device Problem Naturally Worn (2988)

Patient Problems Fall (1848); Pain (1994)

Event Date 04/07/2023

Event Type  Injury  

Event Description

Litigation complaint received ad 6 sep 2023, medical records reviewed by clinician.On (b)(6) 2022, the patient had a right total hip arthroplasty to address osteoarthritis.(lot# pages 6,7 of 8.) depuy products were implanted.On (b)(6) 2023, the patient had a right hip revision of acetabular liner and femoral head to address catastrophic failure.Indications for surgery included patient having pain, multiple falls, and a radiograph demonstrated femoral head high in the cup, which is consistent with catastrophic failure or liner dislocation (disassociation).During the procedure, the surgeon observed that the liner had come loose and had rotated into an inferior position resulting in articulation and impingement of the ceramic head.The femoral head had a significant stripe wear consistent with metal wear.The cup and stem were retained.Depuy pinnacle dual mobility liner, depuy bi-mentum pe liner and depuy articul/eze femoral head were implanted during this procedure.Doi: (b)(6) 2022.Dor:(b)(6) 2023 (head/liner).Right hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.H6 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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.If additional information is made available, the investigation will be updated as applicable.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 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 that 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, b7.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2023 medical records note the patient is 11 weeks post-op and feels pain within the gluteus maximus muscle and is worried about dislocating the hip.The surgeon noted long-standing pain in the right hip despite treatment and normal imaging/physical exam.(this is only 11 weeks post op and pain is an expected outcome while healing postoperatively.No new pc is required at this time).(b)(6) 2023 mri demonstrates right hip arthroplasty, mild increased signal on fluid sensitive sequences along the femoral stem.Moderate right greater trochanteric bursitis versus hematoma/seroma.The patient also reported having weakness and pain.The impression is mild trochanteric bursitis.Iliopsoas tendinitis appears to be from the prominence of the irritating psoas tendon itself.Corticosteroid injection is recommended.(this was captured in (b)(4) ).

• Brand Name: DELTA CER HEAD 12/14 32MM +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 IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17815992
• MDR Text Key: 324215436
• Report Number: 1818910-2023-19424
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031803
• 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,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136532320
• Device Lot Number: 3843514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2022
• 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: ACTIS COLLARED STD SIZE 2; ALTRX +4 NEUT 32IDX48OD; APEX HOLE ELIM POSITIVE STOP; PINN SECTOR W/GRIPTION 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female