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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT'L BIOLOX FORTE CER 36 HD 12/14 +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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SMITH & NEPHEW, INC. INT'L BIOLOX FORTE CER 36 HD 12/14 +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE Back to Search Results
Catalog Number 71331047
Device Problem Noise, Audible (3273)
Patient Problems Failure of Implant (1924); Discomfort (2330)
Event Date 06/11/2021
Event Type  Injury  
Event Description
It was reported that, after a thr surgery had been performed on (b)(6) 2013, with a 60mm reflection fso5 shell, biolox forte ceramic liner 36mm 44g, anthology 8ho and biolox forte 36+0 head, a the patient experienced a squeaking hip and a worn and fractured ceramic liner.A revision thr surgery was performed on (b)(6) 2021, in order to address this problem.The shell, liner and head were explanted and replaced with smith and nephew backup devices.Current health status of patient is unknown.
 
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, patient underwent revision tha for squeaking with ¿worn/fractured ceramic liner¿ approximately 8 years post implantation.It was communicated that the requested clinical documentation and/or explants were not available for inclusion in the medical investigation.Additionally, correspondence reported ¿cannot confirm but likely¿ that all the liner pieces were removed.Without the requested documentation, the clinical root cause of the reported event could not be fully evaluated.Based on the information provided, the squeaking was most likely secondary to the ¿worn/fractured ceramic liner¿; however, the root cause of the fractured liner could not be concluded.The patient impact beyond the reported squeaking, worn/fractured liner, and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available in the future, this case may be re-opened/re-assessed.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 additional complaints for the listed batch.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.Some potential probable causes for this event could include but are not limited to traumatic injury, friction, abnormal loading of limb, excessive forces applied to implant or wear.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.We consider this investigation closed.
 
Event Description
It was reported that, after a thr surgery had been performed on (b)(6) 2013, with a 60mm reflection fso5 shell, biolox forte ceramic liner 36mm 44g, anthology 8ho and biolox forte 36+0 head, a the patient experienced a squeaking hip and a worn and fractured ceramic liner.A revision thr surgery was performed on (b)(6) 2021, in order to address this problem.The shell, liner and head were explanted and replaced with smith and nephew backup devices.It was stated that it is likely that all the pieces of the fractured liner were removed but it cannot be confirmed.Current health status of patient is unknown.
 
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Brand Name
INT'L BIOLOX FORTE CER 36 HD 12/14 +0
Type of Device
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 Key12063544
MDR Text Key258296669
Report Number1020279-2021-05434
Device Sequence Number1
Product Code MRA
UDI-Device Identifier03596010583222
UDI-Public3596010583222
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/10/2021
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
Device Operator Health Professional
Device Catalogue Number71331047
Device Lot Number08AT16280
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received06/24/2021
Supplement Dates Manufacturer Received09/08/2021
Supplement Dates FDA Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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