MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-100

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

Patient Problems Fever (1858); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Fluid Discharge (2686); Renal Impairment (4499); Unspecified Kidney or Urinary Problem (4503); Swelling/ Edema (4577)

Event Date 01/01/2023

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.

Event Description

On (b)(6) 2021 patient reported a lot of blood coming from incision, this is most likely a hematoma, patient advised to apply pressure dressing.On (b)(6) 2021, the patient had a i&d with poly liner and femoral head exchange to address infected/septic total hip.Patient is culture positive for mrsa.The patient presented with swelling, pain and a fever.Depuy poly liner was implanted along with depuy ceramic femoral head.On (b)(6) 2021, the patient was hospitalized due to vancomycin accumulation and acute kidney injury due to iv antibiotic use causing adverse effects.The patient was also experiencing hallucinations and peripheral edema.Patient stopped taking vancomycin and was started on a different antibiotic.Doi: (cup and stem): (b)(6) 2020; doi (head and liner): (b)(6) 2021; right hip.

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.Patient code renal injury was removed and acute kidney failure was added.Patient code swelling/edema (e2338) used to capture swelling and edema.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 : 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.

• Brand Name: SUMMIT POR TAPER SZ4 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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: 16451966
• MDR Text Key: 310329617
• Report Number: 1818910-2023-04616
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059356
• UDI-Public: 10603295059356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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: 02/28/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 1570-01-100
• Device Catalogue Number: 157001100
• Device Lot Number: 9317483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/02/2023; 03/02/2023
• Supplement Dates FDA Received: 03/02/2023; 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ALTRX +4 NEUT 32IDX50OD; APEX HOLE ELIM POSITIVE STOP; DLT TS CER HD 12/14 32MM +5; PINN 100 W/GRIPTION 50MM; SUMMIT POR TAPER SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female