MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF XLPE 32 20 DEG 54-56 F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71333335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that liner continuously can't be implanted into the outer cup.Delay greater than 30 minutes.
Additional Manufacturer Narrative
The associated reflection 3 hole shell and reflection xlpe liners were returned and evaluated.A lab analysis conducted during this investigation indicated that macroscopic examination of the shell revealed minor scuffs on the inner polished surface and on the rim, likely from attempted liner insertion.No significant damage was observed on the porous surface.Liner 1 showed scratches to the non-articulating surface and rim.Liner 2 showed scratches to the non-articulating surface, rim, slot and splines/scallops.The damage on both liners was likely caused by instruments during attempted placement.Dimensional evaluation performed on the cup noted all measured features were found to be within specification.Dimensional evaluation of the two liners noted both parts have visual damage on the inner diameter face, on the hood where the batch laser etch resides and on the bottom face.The outer diameter seems to be free of any significant damage.Based on cmm and overlay verification, spline profile and locking detail are oversized on both liners.All other mating dimensions are within spec.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.With the information currently available we are considering this to be an isolated event.No further investigation is 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: REF XLPE 32 20 DEG 54-56 F
• 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: 8305368
• Report Number: 1020279-2019-00414
• Device Sequence Number: 154201
• Product Code: LPH
• UDI-Device Identifier: 03596010455680
• UDI-Public: 03596010455680
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 71333335
• Device Lot Number: 18AM18565
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1