MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number	71335556
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision surgery performed due to debilitating right hip pain and instability.Also, metallosis and reactive inflammatory fluid surrounding the hip joint were discovered.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation cannot be performed.Should clinical information be provided, the clinical/medical task may be re-evaluated.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Product was sterilized according to sterilization release documentation from quality control.No further clinical/medical investigation is warranted at the time.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for this devices.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that the clinical information provided, stating ¿copious amount of reactive fluid within the joint¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause for the ¿mechanical loosening¿ resulting in the second revision cannot be concluded without supporting documentation.No further investigation is warranted at the time.Without the actual product involved our investigation cannot proceed.If the device or new information is received in the future, these complaints can be re-opened.

• Brand Name: R3 3 HOLE ACET SHELL 56MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7564044
• Report Number: 1020279-2018-01047
• Device Sequence Number: 178826
• Product Code: NXT
• UDI-Device Identifier: 03596010598264
• UDI-Public: 03596010598264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2019

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: 07/23/2021
• Device Catalogue Number: 71335556
• Device Lot Number: 11GM13600
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018; 05/11/2018; 05/11/2018
• Initial Report FDA Received Date: 06/03/2018
• Supplement Report FDA Received Date: 10/30/2018; 10/05/2018; 09/04/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71332530-11GM12304; 71336500-11HM09813
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR