MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE US HD36MM M +4 12/14 TPR +4; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/CERAMIC/METAL,CEMENTEDORUNCEMENTED

Catalog Number	71332085
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.(b)(6) saw a patient in his office because of a ceramic-on-ceramic hip replacement that was done on (b)(6) 2010.The patient had came in with an audible squeak and audible clunk.Dr.(b)(6) revised this patient on (b)(6) 2018.This case was revised to a oxinum head and poly.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical evaluation was conducted and all documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: BIOLOX FORTE US HD36MM M +4 12/14 TPR +4
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/CERAMIC/CERAMIC/METAL,CEMENTEDORUNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8305478
• Report Number: 1020279-2019-00411
• Device Sequence Number: 13719232
• Product Code: MRA
• UDI-Device Identifier: 00885556020241
• UDI-Public: 00885556020241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 05/26/2019
• Device Catalogue Number: 71332085
• Device Lot Number: 09EM18686
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/22/2019
• 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: 71332530/09JT35191; 71335554/09KM07880; 71332530/09JT35191; 71335554/09KM07880
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 33 YR