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

Model Number	71352505
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a left hip revision surgery, performed due to instability.A fracture was found in the femur.
Additional Manufacturer Narrative
The devices, intended for use in treatment, were not returned for evaluation.A visual inspection of the device could not be performed.A relationship between the device and the reported event could not be corroborated.There is no information to suggest the device failed to meet specifications.A clinical evaluation was conducted and the position of the acetabulum cannot be ruled out as a contributing factor to the pain and clinical status of the patient, the pain and pseudocapsule are consistent with metallosis, however without the supporting lab/pathology results or analysis of the explant, the root cause of the reported pain, and metallosis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.A complaint history review found related failures; this failure mode will be trended by post market surveillance to assess for any necessary corrective actions.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 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: 9171677
• Report Number: 1020279-2019-03602
• Device Sequence Number: 16797988
• Product Code: LPH
• UDI-Device Identifier: 03596010619617
• UDI-Public: 03596010619617
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 01/07/2021
• Device Model Number: 71352505
• Device Catalogue Number: 71352505
• Device Lot Number: 09MTM0010N
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention