MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Post Operative Wound Infection (2446)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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

After review of medical records.An operative/procedure notes, on (b)(6) 2022, patient was revised due to right prosthetic joint infection.Patient had right total hip acetabular and femoral components revised.During the removal of femoral component with the skula extraction device which took at least an hour.The explant system was used to remove the cup, and there was a broken stripped screw that they had to remove as well.The femoral head was placed on the prostalac stem and the hip was reduced.Doi: (b)(6) 2008 (unk cup, unk screw, unk stem).Doi: (b)(6) 2020 (unk head, unk liner).Dor: (b)(6) 2022.Right hip.This pc is related to (b)(4) & (b)(4).

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.

Event Description

Medical records were received and stated that on (b)(6) 2022, the patient had a follow-up on patient condition, preparing for discharge.The patient has a history of right tha joint infection requiring i&d on (b)(6) 2020 with a long course of iv antibiotics then transitioned to oral meds.The patient developed breakthrough infection, requiring right hip resection arthroplasty revision on (b)(6) 2022, with the initiation of iv antibiotics through (b)(6) 2022.The resident has decreased mobility to right hip joint due to infected prosthesis and infected surgical wound to right hip.Has joint contracture of bilateral feet.Partial weight bearing to rle.

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: b5, h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• 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: 16402943
• MDR Text Key: 309884484
• Report Number: 1818910-2023-04021
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP CONSTRAINED ACETABULAR LINER PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM; UNKNOWN SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male