MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SYNERGY HIP STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/04/2020

Event Type  Injury  

Event Description

It was reported that after a thr, while patient stepped off a curb, felt a snap.A revision surgery was performed to exchange the synergy stem that broke at neck.A competitor device was implanted and the outcome of the patient is unknown.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A medical investigation was conducted and confirms based on the information provided, the root cause of the reported event likely was the result of the age of the implant and the possible mal-positioning (possible migration) of the acetabular component, although this could not be definitively concluded based on the single x-ray image alone.The patient impact beyond the reported stem fracture and subsequent revision could not be determined as reportedly the patient¿s current was unknown.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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.We consider this investigation closed.

• Brand Name: UNKN SYNERGY HIP STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10885315
• MDR Text Key: 217686499
• Report Number: 1020279-2020-06656
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention