MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number 1221-32-148

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)

Event Date 08/10/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.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

Pinnacle litigation record received.Litigation alleges popping sensation, hip pain, discomfort, decrease range of motion and mental anguish.It was also alleged a deformed and fracture acetabular shell liner implant as the reason for revision.Plaintiff is seeking compensatory damages for all the suffering.Doi: (b)(6) 2013.Dor: (b)(6) 2021.Right hip.

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.

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

On (b)(6)2013, the patient had a right total hip arthroplasty to address osteoarthritis with depuy products implanted.On (b)(6)2021, the patient had a right hip revision to address mechanical failure of polyethylene component and pain.During the procedure the surgeon observed some slight metallic tinged discoloring and polyethylene fragments that were fractured from the poly liner.The femoral head and liner were removed, the cup and stem were retained.Depuy components (bi-mentum pe liner, pinnacle dual mobility liner and articul/eze femoral head) were implanted during this procedure.

• Brand Name: ALTRX +4 10D 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16618216
• MDR Text Key: 312025832
• Report Number: 1818910-2023-06608
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016151
• UDI-Public: 10603295016151
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2023

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 Expiration Date: 07/31/2017
• Device Model Number: 1221-32-148
• Device Catalogue Number: 122132148
• Device Lot Number: 263554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 07/11/2023
• Supplement Dates FDA Received: 03/31/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2012
• 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 10D 32IDX48OD; ARTICUL/EZE BALL 32 +1 GR; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 48MM; SUMMIT POR TAPER SZ3 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female