MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); 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.

Event Description

Literature article entitled: "primary total hip arthroplasty using an anterior approach and a fracture table¿.The article reviews the short term results of 247 total hip replacements from a community hospital by 5 surgeons with limited experience in the anterior approach.152 depuy synthes femoral stems were utilized (42 cemented summit, 77 cementless summit, 19 corail ha coated, 12 trilock, and 3 srom).The manufacturers of the cup and liner were not provided.Post-operative complications included 4 hematomas, 2 calcar fractures, 2 superficial infections, 2 femoral shaft fractures, 14 proximal femoral or gt fractures, 2 deep infections, 2 nerve palsys, 3 with immediate need for revision due to leg length discrepancy, 3 femoral revisions within a year, 5 femoral subsidence within a year, and 8 total femoral loosenings.18 femoral stems demonstrated more than 5 degrees of varus.

Manufacturer Narrative

(b)(4).Investigation summary
=
> 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.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8687288
• MDR Text Key: 147648269
• Report Number: 1818910-2019-95681
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention