MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2017 patient had a computed tomography that showed effusion of the right hip and strongly suggest metallosis and on (b)(6) 2017 and mri was performed and showed abnormal soft tissue signal compatible with pseudotumor along with moderate atrophy of the gluteus medius and mild atrophy of the gluteus maximus.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and the reported elevated metal ion levels, effusion, pseudotumor, and intraoperative findings along with the clinical symptoms are consistent with an adverse reaction to metal debris; however, without the supporting pathology results, imaging, and/or the analysis of the explanted components, the source cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.However, the use of mixed components, smith and nephew products with the mako trinity products cannot be ruled out as a contributing factor to the increased amount of wear debris/¿metallic-stained fluid¿ and ¿metallosis¿ type findings.The future impact to the patient cannot be determine.No further clinical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: SMF STEM WITH STIKTITE SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8206125
• Report Number: 1020279-2018-02950
• Device Sequence Number: 14019824
• Product Code: LPH
• UDI-Device Identifier: 03596010619587
• UDI-Public: 03596010619587
• Combination Product (Y/N): N
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 09/12/2022
• Device Catalogue Number: 71352502
• Device Lot Number: 12MM06165
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 03/29/2019
• 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: 71352112/12FTM0025BFEMORAL HEAD / UNKNOWN; 71352112/12FTM0025BFEMORAL HEAD / UNKNOWN
• Outcome Attributed to Adverse Event: Other