MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX52OD; HIP ACETABULAR LINERS

Model Number 1221-32-152

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Inflammation (1932); Discomfort (2330); Ambulation Difficulties (2544); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Patient initiated complaint: it was reported by the patient that, "there is a possible defect in hip replacement material that was sent and used by my hip surgeon during (b)(6) 2021.As a result, i am now having to be scheduled for a 'revision implant procedure' soon.In the meantime, please make note of the following implant material that was installed into my right hip and just maybe your company will be able to determine what needs to be done next because i have already filed a consumer complaint with the fda on the following hip replacement materials: depuy synthes pinnacle shell size 52; a+4 19-degree liner; summit femoral stem size 4; standard offset; and femoral head is a +1.5 32mm ceramic.I live in (b)(6) and my hip replacement surgery took place in (b)(6) 2021 without any major complications and appropriate physical therapy was also required and completed.The function of my hip with the above materials failed on (b)(6) 2023.I was taking a leisurely walk on a sidewalk when the materials in my hip made a loud popping sound, a buckling down of my hip occurred immediately and then the materials/mechanism has not stopped making squeaking sounds from my hip and femur.

Manufacturer Narrative

Product complaint # : (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.The initial reporter information has been removed for confidentiality/privacy.The initial reporter is a patient.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.

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), was not possible because the required lot code was not provided.Removed pe code implant noise : audible sound.

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 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.

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 (nc search) was performed for the finished device product code:122132152, lot - h79386, and no non-conformances / manufacturing irregularities were identified.

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).Investigation summary; the device associated with this report was not returned to depuy synthes for evaluation.Review of the photographic evidence found the rim of the liner with some anti-rotation device (ard) tabs sheared off.Deformation was also observed on the device's rim indicating that the edge of the liner was loaded by the femoral head and patient's body weight.Based on the observations, it is reasonable to conclude that a disassociation event occurred between the liner and the cup.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot; a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances or manufacturing irregularities were identified.

Event Description

Additional information was received and stated as follows: the previous hip implant from (b)(6)2021 collapsed on (b)(6)2023 when the patient was standing on a slightly slanted part of a sidewalk; the slanted part of the sidewalk is declined in a way to allow wheelchairs, baby strollers, etc., to have better access to a sidewalk from a street.The 2021 implant struggled to maintain its strength while the patient was standing on part of that slanted sidewalk.Prior to the collapse of the implant, the patient was taking a leisurely walk and was in a standing position on the slanted part of the sidewalk when the collapse occurred.

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.

• Brand Name: ALTRX +4 10D 32IDX52OD
• Type of Device: HIP ACETABULAR LINERS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17099513
• MDR Text Key: 316893732
• Report Number: 1818910-2023-11985
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016175
• UDI-Public: 10603295016175
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072963
• 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,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1221-32-152
• Device Catalogue Number: 122132152
• Device Lot Number: H79386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 32MM +1; DELTA CER HEAD 12/14 32MM +1; PINN 100 W/GRIPTION 52MM; SUMMIT POR TAPER SZ4 STD OFF; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR CUP PINNACLE; UNK HIP FEMORAL HEAD CERAMIC; UNK HIP FEMORAL STEM SUMMIT; UNK HIP FEMORAL STEM SUMMIT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR