MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SMF STEM WITH STIKTITE SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71352505
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was required due to mechanical failure and loosening of the stem.
Additional Manufacturer Narrative
The associated complaint device was not returned.Details regarding the patient¿s weight-bearing status, bone quality and fall/trauma history were not provided.Although evidence of metallosis was reported during the revision surgery, no supporting clinical documentation has been provided for review.A medical evaluation of the reported complaint concluded that based on the limited medical information provided, and without the complaint device, the root cause of the reported component loosening and pain cannot be determined.However, the reported articulation between the femoral neck and the liner reported in the intraoperative findings could have been a contributing factor to or a result of the loosening which caused the pain.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: SMF STEM WITH STIKTITE SZ 5
• 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: 8028288
• Report Number: 1020279-2018-02320
• Device Sequence Number: 11060406
• Product Code: LPH
• UDI-Device Identifier: 03596010619617
• UDI-Public: 03596010619617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2019

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: 01/17/2020
• Device Catalogue Number: 71352505
• Device Lot Number: 09MTM0010A
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 10/11/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/15/2018; 05/05/2019
• 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: 71342340/11FM05418; 71344249/10BT39296
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR