MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71336448
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr on (b)(6) 2013 with a ref three hole shell 48mm ((b)(4)), ref xlpe 22 0 deg 46-48 sz ((b)(4)) and a oxinium fem hd 12/14 28mm +4 ((b)(4)), a revision surgery was performed on (b)(6) 2021 due to osteolysis.The products were replaced to competitor's products.The current health status of patient is unknown.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned device could not confirm the stated failure mode.The device is severely worn from use.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that a review of the provided x-rays confirmed osteolysis behind the shell.Also, it was noted that the head isn¿t centered.So there may be poly wear.No further clinical documentation was provided.Therefore, based on the information provided, the clinical root cause of the reported osteolysis cannot be confirmed.The patient impact beyond the revision cannot be determined.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was damaged from use.The inner cavity of the shell was found to be severely worn likely from the insertion and/or removal of the device.One of the screw holes was also damaged likely from the screw used in the assembly.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that a review of the provided x-rays confirmed osteolysis behind the shell.Also, it was noted that the head isn¿t centered.So there may be poly wear.No further clinical documentation was provided.Therefore, based on the information provided, the clinical root cause of the reported osteolysis cannot be confirmed.The patient impact beyond the revision cannot be determined.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could not be corroborated.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was damaged from use.The inner cavity of the shell was found to be severely worn likely from the insertion and/or removal of the device.One of the screw holes was also damaged likely from the screw used in the assembly.A review of complaint history did not reveal similar events for the listed device.The clinical/medical evaluation concluded that a review of the provided x-rays confirmed osteolysis behind the shell.Also, it was noted that the head isn¿t centered.So there may be poly wear.No further clinical documentation was provided.Therefore, based on the information provided, the clinical root cause of the reported osteolysis cannot be confirmed.The patient impact beyond the revision cannot be determined.Should any additional relevant clinical information be provided, this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could not be corroborated.Wear potential causes could include but are not limited to friction, joint tightness or lifetime of device.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.

• Brand Name: REF THREE HOLE SHELL 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 12898342
• Report Number: 1020279-2021-08443
• Device Sequence Number: 20018568
• Product Code: MBL
• UDI-Device Identifier: 03596010454331
• UDI-Public: 03596010454331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/18/2022

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: 07/27/2023
• Device Model Number: 71336448
• Device Catalogue Number: 71336448
• Device Lot Number: 13GM18579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/28/2022; 03/07/2022; 03/07/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/31/2022; 03/12/2022; 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2013
• 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