MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Foreign Body Reaction (1868); Unspecified Infection (1930); Nerve Damage (1979); Joint Dislocation (2374); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Date 12/27/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # : (b)(4).D4-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

This complaint is from a literature source.The following literature cite has been reviewed: zeng wn, zeng l, guo q, yu qp, wang hy, luo zy, pei fx, zhou zk.Long-term clinical outcomes and survivorship of total hip arthroplasty for pyogenic arthritis: a retrospective cohort study of 168 hips.Orthop surg.2022 jan;14(1):55-64.Doi: 10.1111/os.12939.Epub 2021 dec 5.Pmid: 34866335; pmcid: pmc8755883.Objective and methods: the aim of the present study was to evaluate the 10-year outcomes of cementless total hip arthroplasty (tha) in adult patients with the late sequelae of septic arthritis of the hip.168 hips were followed who underwent cementless tha, all of whom had hip osteoarthritis secondary to hip pyogenic infection.Ten patients were excluded due to unrelated death (5 patients) or loss of follow up (5 patients).A cementless duraloc or pinnacle (depuy orthopaedics, warsaw in, usa) acetabular component was press-fit.One of four different types of cementless femoral prostheses (depuy orthopadics) were used: a corail component in 68 hips, a summit component in 17 hips, an s-rom component in 61 hips, and a tri-lock component in 22 hips.2 hips underwent two-stage total hip arthroplasty and chronic antibiotic suppressive therapy.A radiolucent line (0.3 mm-1.2 mm) was observed in 12 hips (9 acetabular interfaces/3 femoral interfaces).Progressive radiolucent line around the undersized femoral stem in all zones was seen in 1 hip, resulting in aseptic loosening and breakage of the femoral component.A larger solution cementless femoral stem (depuy) was used to revise this femoral stem 2.2 years after surgery.One hip with metal-on-metal hip bearing (momhr) surface had pseudotumors around the acetabulum and a peri-acetabular radiolucent line (2.4 mm) in zones i to iii, which resulted in the loosening and a change of the inclination angle of the acetabular cup.An acetabular-only revision was conducted, and the new acetabular component was fixed firmly at final follow-up.Heterotopic ossification was seen in 13 hips: there was 1 case of brooker grade i, 7 of grade ii, and 5 of grade iii.Dislocation of the femoral head (22¿28 mm) occurred in 7 hips.These hips were successfully treated with closed reduction and confinement to bed for 3 weeks without additional recurrence.Transient sciatic nerve palsy occurred in 7 hips who had leg lengthening of 3.68 cm (range 2.9 to 3.9 cm) (crowe type iii in 1 hip, crowe type iv in 4 hips, and other types in 2 hips).These patients recovered fully within 8 months after receiving medication and undergoing rehabilitation exercise.In 8 hips, intraoperative fractures occurred in the femur (6 hips: 2 in the distal and 4 in the proximal femur) and in the greater trochanter (2 hips), which were successfully treated with a cerclage cable.Intraoperative fractures occurred in 5 hips that underwent subtrochanteric osteotomy.One patient had a wound infection and skin-edge necrosis, which was healed completely after debridement and closure.Three patients had thigh swelling due to additional adductor tenotomy.Results: no deep venous thrombosis, nonunion at femoral osteotomy site, and polyethylene wear were seen during follow-up evaluation.Based on the patients in this study, a significant association was observed between intraoperative fractures and transverse subtrochanteric osteotomy and prophylactic cable fixation in the femur.Improved surgical techniques and development of components with various sizes provided favorable results for cementless tha conducted for late sequelae of sepsis in these young and active patients.Although the incidence of complications was relatively high, the complications were treated successfully.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17030188
• MDR Text Key: 316386120
• Report Number: 1818910-2023-11188
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• 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
• Patient Outcome(s): Required Intervention