MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 28 20 DEG 50-52 E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333324
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reflection xlpe 20 degree overlapped acetabular size e did not get seated to the corresponding 52mm reflection 3 hole acetabular shell in a primary thr.Surgeon struggled for almost 45 minutes for getting it locked.Finally, they were forced to remove the two screws and the acetabular shell because of this issue (though the acetabular shell and screws fixed perfectly) and implanted a same size cemented reflection all poly cup with bone cement.
Additional Manufacturer Narrative
It was reported that the liner cannot match with the acetabular cup.The associated reflection xlpe liner, reflection 3 hole shell and screws were returned and evaluated.A dimensional evaluation was completed on the returned shell for all critical features, and the failure mode could not be confirmed through this evaluation.A dimensional inspection was attempted on the liner; the damage/deformation at several features of the device would not allow for accurate measurement.The liner showed some marking and scoring on the face of the device.These marks were likely by instrumentation during the attempts to impact.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 could not be corroborated.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REF XLPE 28 20 DEG 50-52 E
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8107736
• Report Number: 1020279-2018-02611
• Device Sequence Number: 16673716
• Product Code: LPH
• UDI-Device Identifier: 03596010455611
• UDI-Public: 03596010455611
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71333324
• Device Lot Number: 18AM18560
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 11/08/2019
• 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: 71332525/ 18EM11897; 71332530/ 18EM05868; 71336452/ 18DM17991; (B)(4); (B)(4); (B)(4)