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 Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 09/03/2020

Event Type  Injury  

Event Description

On 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 15 revision surgeries were performed due to loosening of the implant while using a synergy stem.

Manufacturer Narrative

Please refer to attachments.

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 confirms the literature review ¿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.¿ noted 15 revision surgeries were performed due to loosening of the implant while using a 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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: 11231624
• MDR Text Key: 228731085
• Report Number: 1020279-2021-00608
• 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,Followup
• Report Date: 04/26/2021

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 01/05/2021; 01/05/2021
• Supplement Dates FDA Received: 01/27/2021; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention