MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/29/2015

Event Type  Injury  

Event Description

The right hip was revised due to pain and the presence of a soft tissue reaction.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR ACETABULAR CUP 58MM
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau, FL 5001 ; SZ 5001
• MDR Report Key: 5232157
• MDR Text Key: 31450455
• Report Number: 3005477969-2015-00299
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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 Expiration Date: 03/31/2013
• Device Catalogue Number: 74122158
• Device Lot Number: 08CW16059 003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2008
• 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
• Treatment: FEMORAL STEM, # 71357005, LOT # 07MM01048A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR