MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ECHELON HA STD 260 BOW S 12 L; PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,CALICUMPHOSPHATE

Model Number	71344412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tha was performed on an unspecified date, the patient experienced a joint capsule infection and the echelon ha std 260 bow s 12 l was broken.This adverse event was solved by a revision surgery on (b)(6) 2021, in which the ref no hole shell sz 52mm, echelon ha std 260 bow s 12 l, oxinium fem hd 12/14 32mm +8 and an unknown reflection liner were explanted.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes for the infection could include but are not limited to contamination, patient reaction, and post-operative healing issue.Some potential probable causes for the breakage could include but not limited to traumatic injury or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.

• Brand Name: ECHELON HA STD 260 BOW S 12 L
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,UNCEMENTED,METALPOLYMER,CALICUMPHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12847152
• Report Number: 1020279-2021-08246
• Device Sequence Number: 19894986
• Product Code: MEH
• UDI-Device Identifier: 00885556023549
• UDI-Public: 00885556023549
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: 12/16/2021
• Device Model Number: 71344412
• Device Catalogue Number: 71344412
• Device Lot Number: 11LM03195A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown