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); Inflammation (1932); Nerve Damage (1979); Joint Dislocation (2374); Post Operative Wound Infection (2446)

Event Date 03/15/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled "long-term clinical outcomes and survivorship of total hip arthroplasty for pyogenic arthritis: a retrospective cohort study of 168 hips" written wei-nan zeng, md, phd, lin zeng, mm, qiang guo, md, qiu-ping yu, bn, hao-yang wang, md, ze-yu luo, phd, fu-xing pei, md, zong-ke zhou, md, phd published by orthopaedic surgery on december 27, 2020, was reviewed.Thus, the purpose of this study was: to determine the efficiency of cementless tha for patients with suppurative arthritis of the hip; to evaluate the long-term clinical and radiographic outcomes of patients; and to evaluate patient complications.168 hips were included in the study and follow up for 5 years.Depuy synthes implants: cementless duraloc or pinnacle cups were placed with the target position of 40.Degrees +/- 10 for abduction and 15 degrees +/- 10 for anteversion.Screws were placed in 66 hips.Cementless femoral components were corail (68), summit (17), srom (61 hips), and trilock (22 hips) adverse events: 2 patients had a recurrence of infection (different organism).Both patients underwent two-stage tha and chronic antibiotic suppressive therapy.Radiographic evaluation noted the mean abduction and anteversion of the acetabular cup to be outside the above targeted position.There was no mention of the number involved or any treatment included.1 patient ((b)(6) male) a progressive radiolucent line around the undersized summit femoral stem which resulted in aseptic loosening and breakage of the femoral stem.A larger solution stem was placed.1 patient had metal on metal hip bearing with psuedotumors around the acetabulum which resulted in cup loosening.And a change in the inclination angle of the cup.An acetabular revision was completed.13 patients had heterotopic ossification.No treatment was noted.7 patients reported dislocations and all were treated with closed reductions.7 patients had transient sciatic nerve palsy.Patients fully recovered within 8 months after receiving medication and undergoing rehab exercises.8 patients experienced intra-op femoral fractures that were treated with cerclage cables.1 patient experienced a wound infection and skin-edge necrosis, which was healed completely after debridement and closure.3 patients had thigh swelling due to additional abductor tenotomy.No treatment noted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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: 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): 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: 13980029
• MDR Text Key: 288862537
• Report Number: 1818910-2022-05998
• 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: 04/01/2022

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 HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 06/14/2022
• 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