MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR FEM COMP SZ 17; PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEM

Model Number	71306617
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	12/13/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the doctor had to make a medical intervention due to fissure at the femur.
Additional Manufacturer Narrative
It was reported that during surgery the doctor had to make a medical intervention due to fissure at the femur.The affected synergy porous stem, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.It was communicated that this adverse event has been resolved, no further harm is being alleged to this patient.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.Possible causes could include but are not limited to surgical technique or bone quality.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: SYN POR FEM COMP SZ 17
• Common Device Name: PROSTHESIS, HIP, SEMI-CONS, METAL/POLYMER, POROUS UNCEM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9520494
• Report Number: 1020279-2019-04603
• Device Sequence Number: 595482
• Product Code: LPH
• UDI-Device Identifier: 03596010194510
• UDI-Public: 03596010194510
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: No Information
• Device Expiration Date: 07/10/2020
• Device Model Number: 71306617
• Device Catalogue Number: 71306617
• Device Lot Number: 10GM06425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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: 71331858-08LM08214.; 71335758-10CM14825.; 71343600-10KM07239.; ACETABULAR LINER, # 71335758, LOT # 10CM14825.; ACETABULAR SHELL, # 71331858, LOT # 08LM08214.; OXINIUM HEAD, # 71343600, LOT # 10KM07239.; 71331858-08LM08214; 71335758-10CM14825; 71343600-10KM07239
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77