MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN MEMPHIS RECON HIP INSTR; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKNOWN

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

Patient Problem Injury (2348)

Event Date 07/22/2020

Event Type  Injury  

Event Description

It was reported that patient was treated for a neck of femur fracture in (b)(6) 2019, using zimmer dhs and cannulated screws to reduce the fracture.According to the surgeon, the patient had a non union of the neck of femur fracture and was booked for a direct anterior approach total hip replacement using the purist table provided by smith and nephew.During surgery, after the zimmer dhs and cannulated screws were removed, the surgeon dissected and exposed the acetabulum as per normal, templeted a 46mm r3 cup, and selected a 42mm reamer to begin reaming the acetabulum.Surgeon began reamed the acetabulum, and the reamer perforated the acetabular wall.Surgeon reamed to the appropriate size (46mm), and then he decided to treat the hole in the acetabulum, he used bone graft, then stryker acetabular mesh, and more bone graft to graft, stabilize, and fill the hole in the acetabulum.And cemented in a 46mm x28mm reflection allpoly cup.After assessing the fracture, surgeon decided to treat the fracture non surgically at the time and placed the patient into a plaster cast.The surgery was finished with a delay of approximately 15 minutes.

Manufacturer Narrative

It was reported that during surgery, after the zimmer dhs and cannulated screws were removed, the surgeon dissected and exposed the acetabulum as per normal, templeted a 46mm r3 cup, and selected a 42mm reamer to begin reaming the acetabulum.Surgeon began reamed the acetabulum, and the reamer perforated the acetabular wall.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.There is not sufficient information to verify the device involved, therefore no potential causes of the reported event could be determined.Without the return of the actual product involved, our investigation of this report is inconclusive.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: UNKNOWN MEMPHIS RECON HIP INSTR
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10418510
• MDR Text Key: 203273274
• Report Number: 1020279-2020-03993
• Device Sequence Number: 1
• Product Code: JDH
• 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: 10/21/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 10/16/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR