MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM SUMMIT

Catalog Number UNK HIP FEMORAL STEM SUMMIT

Device Problems Loss of or Failure to Bond (1068); Osseointegration Problem (3003); Migration (4003)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Physical Asymmetry (4573)

Event Date 03/20/2023

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

Clinical notification received for revision due to aseptic loosening.Date of implant: (b)(6) 2020, date of revision: (b)(6) 2023.(right hip).Treatment: stem, head, and liner were revised.

Event Description

Medical records received.On (b)(6) 2020, patient was seen in office following a fall, with pain in right hip and knee--patient is status-post hip pinning for a prior treatment of femoral neck fracture.She has known severe right knee tricompartmental djd and is waiting to undergo a tka due to an episode of septic arthritis of the right knee last fall.Previous cortisone injection was (b)(6) 2020.Her medical history includes: sjogren syndrome (treated with plaquenil and tramadol).Peripheral neuropathy.Fibromyalgia.Atypical rheumatoid arthritis.Pseudogout.Behcet's disease.On (b)(6) 2020, patient's hip was operated on, for conversion of failed hip pinning to right total hip arthroplasty, with also early right hip degenerative joint disease.It was found that there was a malunion/non-union of the femoral neck with collapse, and loss of articular cartilage from the acetabulum and femoral head.Patient received ingrowth pinnacle cup with two screws, summit cemented femoral stem, with altrx neutral polyethylene liner, and +5 36mm ceramic biolox head.Patient experienced no intraoperative complications.On (b)(6) 2023, patient was seen in office for right leg pain, right leg shortening, and radiolucent identified subsidence and aseptic loosening of the femoral stem.On (b)(6) 2023, patient's hip was revised to address thigh pain, femoral stem subsidence, and aseptic loosening of the femoral stem, at the implant to cement, and cement to bone interfaces.The polyethylene liner showed some wear.Stem was replaced with a reclaim stem.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d4, d10 (concomitant), h6 health effect - clinical code & medical device problem code.

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.

• Brand Name: UNK HIP FEMORAL STEM SUMMIT
• Type of Device: 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16897267
• MDR Text Key: 314851574
• Report Number: 1818910-2023-09939
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

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 Catalogue Number: UNK HIP FEMORAL STEM SUMMIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/11/2023; 05/23/2023
• Supplement Dates FDA Received: 05/22/2023; 05/24/2023
• 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 LINER POLY; UNK HIP FEMORAL HEAD CERAMIC; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic