MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD ACETLR CUP HAP 56MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)

Event Date 06/05/2017

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to pain, limited motion, metallosis and other complications.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to pain, limited motion, metallosis, elevated metal ions in blood.During the revision the bhr head and bhr cup were removed.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.The available medical documents were reviewed.This (b)(6) patient a underwent a right bhr revision approximately 7.5 years post implantation due to report of pain, limited motion, elevated metal ions and mechanical complication.The revision op-report states that there was a cam impingement area of the femur and the acetabular component was in a retroverted and significantly over abducted orientation.The revision op-report also stated that intraoperatively there was no sign of purulence, no evidence seen of pseudotumor, soft tissue damage, or significant sign of metallosis.Neither supporting intra-op pathology findings nor lab results have been provided, which indicate the metal ion level.The reported clinical symptoms of pain, elevated metal ions may be consistent with an adverse reaction to metal debris, however this cannot be confirmed based on the information provided as it was reported that signs of metallosis were not seen grossly.The source of the elevated metal ions cannot be determined.The report of cam impingement cannot be excluded as a contributing factor to the reported complaint of limited motion.Without return of the actual devices or further information we cannot further investigate or confirmthe details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: ACETLR CUP HAP 56MM W/ IMPTR
• 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: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7094948
• MDR Text Key: 94079688
• Report Number: 3005975929-2017-00443
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 096100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR