MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH CEM BOW SZ 12R 300MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71315112
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to a broken echelon stem.
Additional Manufacturer Narrative
It was reported that revision surgery was performed due to a broken echelon stem.The affected echelon cemented bowed stem along with the cocr head were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were observed on the neck of the femoral stem component and a large gouge present on the lateral face of the device distal portion.No visual signs of cement were found on the stem, including the grit blasted proximal portion and the underside of the calcar collar.The stem fracture occurred approximately 110mm from the head center.Given the darkened discoloration of the stem fracture in the lateral-posterior regions it is likely the fracture initiated here.The specific site of fracture initiation or cause of fracture could not be determined during this investigation.Scratches were present on the articulating surface and around the female taper of the head.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the stem revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: ECH CEM BOW SZ 12R 300MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8859664
• Report Number: 1020279-2019-02894
• Device Sequence Number: 13953378
• Product Code: JDI
• UDI-Device Identifier: 03596010440563
• UDI-Public: 03596010440563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2023
• Device Catalogue Number: 71315112
• Device Lot Number: 13AM12572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: 71303604 / LOT NUMBER: 12GM16714.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention