MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECH CEM 15MM CAL SZ 12 175; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71310312
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha had been performed on (b)(6) 2015, the echelon cemented stem broke, likely due to minimal medial bone support of the stem 4-5cm below body.It happened while the patient was showering, so a very low energy breakage.The stem was revised.The patient outcome is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per complaint details, a revision was performed approximately 5.9 years post implantation for a stem fracture which was reportedly ¿likely due to minimal medial bone support of the stem¿ with a ¿very low energy breakage.It was communicated that medical documentation would not be available for inclusion in the medical investigation.The patient impact beyond the reported revision itself could not be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ECH CEM 15MM CAL SZ 12 175
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10613190
• Report Number: 1020279-2020-05010
• Device Sequence Number: 1282579
• Product Code: JDI
• UDI-Device Identifier: 03596010328571
• UDI-Public: 03596010328571
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K983834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2017
• Device Model Number: 71310312
• Device Catalogue Number: 71310312
• Device Lot Number: 07BM13835
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention