MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HIP IMPLANT; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	71341940
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
After several dislocations and a poly exchange, revision surgery was performed on (b)(6) 2019.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to disassociation.The affected reflection interfit 3 hole porous acetabular shell, oxinium head and reflection anteverted liner were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were found on the poly liner.Damage was found on the articular surface of the femoral head.A similar wear pattern to the femoral head was found on the inner surface of the shell.Bone or bone cement attachment was found on the outer surface of the shell.Due to the wear patterns found on the head and the inner surface of the shell, the liner may have disassociated from the shell.No material or manufacturing deviations were observed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to disassociation.The affected reflection interfit 3 hole porous acetabular shell, oxinium head and reflection anteverted liner were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were found on the poly liner.Damage was found on the articular surface of the femoral head.A similar wear pattern to the femoral head was found on the inner surface of the shell.Bone or bone cement attachment was found on the outer surface of the shell.Due to the wear patterns found on the head and the inner surface of the shell, the liner may have disassociated from the shell.No material or manufacturing deviations were observed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to disassociation.The affected reflection interfit 3 hole porous acetabular shell, oxonium head and reflection anteverted liner were returned and evaluated.A lab analysis conducted during this investigation indicated that scratches were found on the poly liner.Damage was found on the articular surface of the femoral head.A similar wear pattern to the femoral head was found on the inner surface of the shell.Bone or bone cement attachment was found on the outer surface of the shell.Due to the wear patterns found on the head and the inner surface of the shell, the liner may have disassociated from the shell.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A medical analysis noted that as the liner may have been dislocated from the shell at some point but with the patient ambulating with a disassociated hip it cannot be concluded if this contributed to the event or a result of the ambulation after the disassociation.Possible causes could include but are not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: HIP IMPLANT
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9222234
• Report Number: 1020279-2019-03706
• Device Sequence Number: 459464
• Product Code: JDH
• UDI-Device Identifier: 00885556112441
• UDI-Public: 00885556112441
• Combination Product (Y/N): N
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/11/2020

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: 06/06/2020
• Device Model Number: 71341940
• Device Catalogue Number: 71336052
• Device Lot Number: 10FM05434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 09/25/2019; 09/25/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/30/2019; 12/30/2019; 03/11/2020
• 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