MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122546

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 11/26/2018

Event Type  Injury  

Event Description

It was reported that the patient had a bhr surgery in the left hip.Due to pain, limited mobility and elevated metal ion levels as a result of the premature failure of the devices.Bilateral patient, right hip in complaint (b)(4).

Manufacturer Narrative

D1, d4 and d10 corrected.

• Brand Name: HEMI HEAD 46MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• MDR Report Key: 9938038
• MDR Text Key: 187007793
• Report Number: 3005975929-2020-00103
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122546
• Device Lot Number: 10720
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 74222100 MODULAR SLEEVE -4MM 12/14 L#UNK.; MODULAR SLEEVE, # 74222200, LOT # 07KW14226.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR