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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Thrombosis (2100); Pressure Sores (2326); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Literature article received entitled "bipolar femoral head arthroplasty in osteoarthritis".Literature article entitled, ¿bipolar femoral head arthroplasty in osteoarthritis a prospective study with a minimum 5-year follow-up period¿ by r.Pandit, et al, published in the journal of arthroplasty (1996), vol.11, no.5, pp.560-564 was reviewed for mdr reportability.Primary bipolar femoral head arthroplasties performed on 100 osteoarthritic hips of physically active patients were studied to a minimum of 5 years after surgery.One hundred hips in 92 patients constituted the study group.No patients were lost to follow-up evaluation.The average age at surgery was 64.6 years (range, 34-79 years; median, 66 years).The right hip was replaced in 53 patients and the left hip in 46 patients.The 3m upf ii bipolar acetabular/ femoral head component was used in all patients.The femoral component for all patients was either a cemented (n=71) or cementless (n=29) aml femoral stem by depuy.Perioperative complications included one each of pulmonary embolism, clinical deep venous thrombosis, trochanteric nonunion, decubitus ulcer, upper gastrointestinal bleeding, and ulnar neuropraxia.There were no lower extremity nerve palsies, infections, or deaths.The only revisions in this study pertained to fracture of the polyethylene liner, misposition of the cup, complete bearing disassembly, and joint dislocations of the femoral head- all components manufactured at 3m.The average pain score in these cases was 9 (range, 6-10).In 34 hips, the patients had no pain (score of 10) and were extremely pleased with the results of the operation.In another 34 hips, the patients reported start-up discomfort or stiffness with the initial few steps on attempted walking after arising from a sitting position.This start-up stiffness, though not a major hindrance, downgraded the pain score to 8.There were no reports of revisions or further complications of the femoral stem from depuy.Heterotopic bone formation was observed in 40 hips.It was grade i in 19, grade ii in 15, grade hi in 4, and grade 1v in 2 hips.The authors do not specify the location of the ossification.Medical intervention was needed for the postoperative complications.There were no revisions of the femoral stem.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8986065
• MDR Text Key: 161675038
• Report Number: 1818910-2019-103720
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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 Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention