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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/01/1991

Event Type  Injury  

Event Description

In the literature article ¿clinical orthopaedics and related research 2020 - is the survivorship of birmingham hip resurfacing better than selected conventional hip arthroplasties in men younger than 65 yeas of age? a study from australia orthopaedic association national joint replacement registry.¿, it was reported that 17 revision surgeries were performed due to infection of the implant while using unknown stem.

Manufacturer Narrative

H3, h6: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So, the reported event could not be confirmed.A medical investigation was conducted and literature review noted 17 revision surgeries due to infection while using unknown synergy hip imp (synergy stem).Smith and nephew has not received the explanted devices or adequate patient-specific materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11235590
• MDR Text Key: 228837146
• Report Number: 1020279-2021-00646
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention