MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOLOX FORTE CER 28 HD 12/14 +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Model Number	71330284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a right tha performed in 2000 (specific date is unknown), the patient experienced pain and squeaking sound in the articulation.A revision surgery was performed on (b)(6) 2021 to treat these adverse events.The biolox forte cer 28 hd 12/14 +4 (case-(b)(4)), the liner (case-(b)(4)) and the r3 3 hole acet shell 54mm (case-(b)(4)) were removed during the revision surgery.More details about the surgery are unknown.The patient outcome is unknown.
Additional Manufacturer Narrative
H6: the device, intended for use in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical / medical investigation concluded that, based on the information provided, the root cause of the squeaking and pain cannot be confirmed.Wear from the time implanted cannot be ruled out.The assessed patient impact was the squeaking, pain, osteolysis and subsequent revision.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 could include but not limited to traumatic injury, joint tightness, alignment, fit/size, wear or lifetime of device used.Based on this investigation, the need for corrective action is not indicated.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: BIOLOX FORTE CER 28 HD 12/14 +4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12076083
• Report Number: 1020279-2021-05458
• Device Sequence Number: 4187102
• Product Code: MRA
• UDI-Device Identifier: 00885556019726
• UDI-Public: 00885556019726
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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 Model Number: 71330284
• Device Catalogue Number: 71330284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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
• Patient Age: 64 YR