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

Catalog Number	74122256
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed.
Additional 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
• Common Device Name: 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: 6979016
• Report Number: 3005975929-2017-00383
• Device Sequence Number: 13946838
• Product Code: NXT
• UDI-Device Identifier: 03596010552372
• UDI-Public: 03596010552372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 74122256
• Device Lot Number: 07EW11849
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR