MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC STD 125MM 5 CBL TROCH GRIP; CERCLAGE, FIXATION

Catalog Number	71340011
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the patient's trochanteric region and greater trochanter was completely ununited.The cables and claw were removed.The trochanteric nonunion was fixed by reapproximating the greater trochanter in the appropriate position and placing a new cable claw construct in the appropriate position.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review revealed no additional complaints for the associated batch.The clinical/medical team concluded unable to rule out the malpositioned prosthesis, leg-length discrepancy, ¿infection treatments¿, and continued motion along with the patient¿s comorbidities as likely contributing factors to the reported non-union of the trochanteric region/gt.However, without the supporting operative reports, lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause cannot be determined and a causal relationship with the cables cannot be confirmed.The patient impact beyond the reported non-union, left hip revision left trochanteric/gt orif and expected post-op convalescence cannot be determined.No further medical assessment is warranted at this 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.No further actions are being taken at this time.

• Brand Name: ACC STD 125MM 5 CBL TROCH GRIP
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7808613
• Report Number: 1020279-2018-01606
• Device Sequence Number: 16407232
• Product Code: JDQ
• UDI-Device Identifier: 03596010485809
• UDI-Public: 03596010485809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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 Catalogue Number: 71340011
• Device Lot Number: 17HSM0052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 05/13/2019
• 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