MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 15; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71306615
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to a fracture of femoral stem.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, it was reported that right hip revision surgery was performed due to a fracture of the femoral stem.The revision operative report noted there was nothing to indicate what could have caused the fracture.The explants were sent to evaluation, but the results were not provided.Conclusion: it was noted during revision that there was nothing to indicate what could have caused the fracture of the femoral stem.The explanted stem was reported to have been sent to for evaluation; however, no results were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported fractured femoral stem cannot be confirmed and it cannot be concluded that the reported event was 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.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.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.We consider this investigation closed.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation, reporting event could not be confirmed.These devices were manufactured in 2007, 2008, 2009 and 2010.A clinical evaluation was conducted and it was noted during revision that there was nothing to indicate what could have caused the fracture of the femoral stem.The explanted stem was reported to have been sent to for evaluation; however, no results were provided for review.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported fractured femoral stem cannot be confirmed and it cannot be concluded that the reported event was associated with a mal-performance of the implant.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the risk management file and instructions for use document for this failure mode was conducted.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file includes but not limited to traumatic injury, lifetime of device, and overuse.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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: SYN POR FEM COMP SZ 15
• 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: 7993126
• Report Number: 1020279-2018-02245
• Device Sequence Number: 1214205
• Product Code: LPH
• UDI-Device Identifier: 03596010194497
• UDI-Public: 03596010194497
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2020

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: 09/26/2017
• Device Model Number: 71306615
• Device Catalogue Number: 71306615
• Device Lot Number: 07JM19311
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018; 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 05/08/2019; 04/28/2020
• 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: 71332545/08JT23989; 71335558/10CM05820; 71335758/09CM00044; 71336530/10FM09536; 71343612/09CM18319
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR