MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF CNSTR LNR 0 DEG 28 54-56 F; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	71323125
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken liner.Patient had a previous revision surgery due to dislocation on "date".
Additional Manufacturer Narrative
Additional information: event.
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.Patient had a previous revision surgery due to a broken liner on "9/5/2018".
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.The liner was found broken when it was explanted.
Additional Manufacturer Narrative
The associated reflection constrained liner was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on the limited information provided it cannot be determined whether the patient's recurrent left hip dislocation was directly associated with the report of the device failing or whether other concomitant factors may have contributed to the reported issue.Therefore, based on insufficient information, a thorough clinical assessment cannot be rendered.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated reflection constrained liner was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that based on the limited information provided it cannot be determined whether the patient's recurrent left hip dislocation was directly associated with the report of the device failing or whether other concomitant factors may have contributed to the reported issue.Therefore, based on insufficient information, a thorough clinical assessment cannot be rendered.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however smith and nephew 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: REF CNSTR LNR 0 DEG 28 54-56 F
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8536195
• Report Number: 1020279-2019-01631
• Device Sequence Number: 10862858
• Product Code: KWZ
• UDI-Device Identifier: 03596010480057
• UDI-Public: 03596010480057
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K021803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 05/12/2021
• Device Catalogue Number: 71323125
• Device Lot Number: 11MM05073
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 06/04/2019; 06/04/2019; 06/04/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/31/2019; 06/06/2019; 08/13/2019; 08/20/2019
• 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: 71323145/16MM03607 ADAPTER; 71335156/UNKNOWN CUP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention