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	02/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an mri of the patient right hip revealed consistent findings with pseudotumor associated with the right hip arthroplasty with large complex soft tissue fluid.Revision surgery was recommended.On (b)(6) 2018, he underwent removal of his devices.Out of concern that the cloudy fluid encountered intraoperative was suspicious for infection, all of his components were removed and a temporary spacer was implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and based on the clinical symptoms of the reported elevated cobalt, corrosion, and hip pain may be consistent with an adverse reaction to metal debris but this cannot be confirmed based on the information provided.The source of the elevated metal ions cannot be determined.It is unknown if the mri reported "significantly anteverted acetabular cup" was a change from implant and if the positioning lead to wear.The greater trochanteric fracture was likely as the physician stated; "secondary to difficulty removing the femoral component"."the future impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.A review of complaint history on the listed parts revealed no prior complaint for the listed batches with the same failure mode.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.We consider this investigation closed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.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 based on the clinical symptoms of the reported elevated cobalt, corrosion, and hip pain may be consistent with an adverse reaction to metal debris but this cannot be confirmed based on the information provided.The source of the elevated metal ions cannot be determined.The greater trochanteric fracture was likely as the physician stated; ¿secondary to difficulty removing the femoral component.¿ ¿the future impact to the patient beyond the revision cannot be concluded.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints 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 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: 7576236
• Report Number: 1020279-2018-01073
• Device Sequence Number: 2221537
• Product Code: LPH
• UDI-Device Identifier: 03596010619587
• UDI-Public: 03596010619587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2019

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: 02/27/2023
• Device Catalogue Number: 71352502
• Device Lot Number: 13CM00586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 11/14/2019
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/30/2018; 11/17/2019
• 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: 71303608/13HM14961.; 71331858/13JM10784.; 71338558/07KM12796.; 71352117/12KTM0017A.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR