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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/01/2014

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 entitled, ¿ultrasound-guided percutaneous tenotomy for the treatment of iliopsoas impingement: a description of technique and case study¿ by matthew j.Sampson, et al, published by journal of imaging and radiation oncology (2015), vol.59, pp.195-199, was reviewed for mdr reportability.This article describes an alternative ultrasound-guided percutaneous technique, achieving iliopsoas tenotomy utilizing a modified 18g coaxial needle and thus minimizing the morbidity and cost associated with an open or arthroscopic procedure.This method proved successful with resultant complete resolution of patient symptoms.This article is a case report of one such procedure.A male patient age (b)(6) who was experiencing symptoms of iliopsoas impingement post right thr (corail pinnacle; polyethylene/metal) for osteoarthritis.Seven months post thr, the patient reported worsening right groin pain that was incapacitating, ranging from 8/10 to 10/10 in severity.Physical examination demonstrated groin tenderness and reproduction of symptoms upon stressing the iliopsoas tendon consistent with impingement.Ultrasound demonstrated a thickened iliopsoas tendon and bursa with focal tenderness on transducer pressure.An ultrasound-guided iliopsoas bursal injection of 2 ml steroid and 3 ml 0.75% ropivacaine resulted in partial relief of symptoms for approximately 3 weeks.Upon relapse of symptoms, the decision was made to proceed to iliopsoas tenotomy via guided ultrasound under anesthesia.The cup and stem were well-fixed and in proper position.The surgeons decided to perform the tenotomy because there was no need to revise the implanted tha.The procedure was successful and at 9 weeks follow-up, the patient had complete resolution of pain and joint movement impairment.Captured in this complaint: 1 pinnacle cup and 1 corail stem.".

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes 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.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per (b)(4).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 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: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9224124
• MDR Text Key: 163599807
• Report Number: 1818910-2019-111306
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

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 HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/24/2019
• 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