MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EMP13 SLV MED CONE2 SPOUT SLOT; PROSTHESIS SEMCONSTRAINED UNCEMENTD MTALPOLYMER, NONPOROUS, CALICUM-PHOSPHATE

Catalog Number 71291665

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/04/2018

Event Type  Injury  

Event Description

The dr revised an emperion stem that had been implanted approximately 9 years ago.The stem had fractured inside the top of the cone.The cup was left in situ.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.The lab analysis concluded, the stem was fractured in the proximal sleeve taper region.Radial lines were observed on the fracture surface.Signs of fretting on the lateral side of the proximal taper region of the stem were observed.The crack initiated most likely in the lateral region of the stem.Bone ongrowth was observed on the porous coated regions of the sleeve.Scratching and damage was observed on the porous coated regions of the sleeve and the distal region of the stem that likely occurred during removal of components.The analysis showed that the emperion stem fractured likely occurred in the lateral region of the stem.Fatigue was most likely the fracture mechanism.No defects in material or manufacturing were found during the course of this evaluation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.The clinical/medical team concluded, based on the results of the product analysis fatigue was most likely the fracture mechanism.However, the length of time in-situ, as well as the patient¿s weight of 148kg/325.6lbs, and lack of bone support around the proximal stem, cannot be ruled out as contributing factors.The future impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: EMP13 SLV MED CONE2 SPOUT SLOT
• Type of Device: PROSTHESIS SEMCONSTRAINED UNCEMENTD MTALPOLYMER, NONPOROUS, CALICUM-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7550350
• MDR Text Key: 109445304
• Report Number: 1020279-2018-01015
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010561701
• UDI-Public: 03596010561701
• Combination Product (y/n): N
• PMA/PMN Number: K042127
• 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: 01/25/2019

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: Lay User/Patient
• Device Catalogue Number: 71291665
• Device Lot Number: 09BAB0045
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 148