MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA SO STEM SZ 13; PROSTH, HIP, SEMI-CONSTR, UNCEMENTED, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number O71309013

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Date 06/11/2019

Event Type  Injury  

Event Description

It was reported that patient started to experience pain, an x-ray was performed and it was noticed that the stem had tipped into various and a small opening the lateral side of the stem was visible.Due to this a revision surgery was performed, stem was removed confirming it was broken.To remove the distal section of the broken stem, a window osteotomy was made to access the broken section and was very well fixed.Once removed the femur was prepared as per the surgical technique, stem and head were implanted.

Manufacturer Narrative

The affected synergy porous plus standard offset stem was not returned for evaluation.Therefore a product analysis could not be performed.However, device details were provided.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 clinical evaluation noted that the lack of proximal bony ingrowth reported in the complaint would most likely be a contributing factor to the reported stem fracture and revision.The patient impact beyond the reported pain and revision could not be determined.Should clinical documentation becomes available in the future, the clinical/medical task may be re-evaluated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit cannot be issued for this device.

• Brand Name: SYN POR PLUS HA SO STEM SZ 13
• Type of Device: PROSTH, HIP, SEMI-CONSTR, UNCEMENTED, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 8746781
• MDR Text Key: 149613565
• Report Number: 1020279-2019-02522
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K002996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: O71309013
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/29/2019
• Supplement Dates Manufacturer Received: 09/22/2019
• Supplement Dates FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention