MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122256

Device Problem Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 09/19/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.

Manufacturer Narrative

It was reported that right hip revision surgery was performed due to an infection.During the first stage of the revision the modular head, bhr dysplasia cup, 2 x dysplasia screws, 1 x cortical screw, sleeve, stem and centraliser were removed.A spacer was implanted before completion of the revision 3 days later.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 and sterilisation 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.Based on the provided operation record from a two-stage revision, the reason for this revision can be assumed to be due to infection.Further investigation was not provided in this regard.An infection developed more than two years after implantation is a late infection.Late infections are normally acquired hematogenously and are not the result of intraoperative contaminations.Since no results of a microbiological analysis were received, further assessment regarding these circumstances could not be performed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.The available information suggests that a late infection has occurred, necessitating the total revision of the components which is not related to the devices originally implanted or their sterility and is not a device related revision.However 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: BHR DYSPLASIA CUP 56MM
• 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 5001 ; SZ 5001
• MDR Report Key: 6979016
• MDR Text Key: 90281775
• Report Number: 3005975929-2017-00383
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552372
• UDI-Public: 03596010552372
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 74122256
• Device Lot Number: 07EW11849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2007
• 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: DYSPLASIA SCREW, # 74500072, LOT # 07AT05161; DYSPLASIA SCREW, # 74500072, LOT # 0EM11017; FEMORAL CENTRALISER, # 71313104, LOT # 09AM16182; FEMORAL STEM, # 71312102, LOT # 09FT32521; FIXATION SCREW, # 3571149754, LOT # 05CT88059; MODULAR HEAD, # 74222148, LOT # 08LW20316; MODULAR SLEEVE, # 74222100, LOT # 08LW19877
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR