MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF LNR 28X50-52 20 DEG SZ E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	71742850
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 2 hour delay occured during a total hip replacement due to a reflection liner and an acetabular cup that could not be implanted.
Additional Manufacturer Narrative
The associated reflection acetabular liner was returned and evaluated.A lab analysis conducted during this investigation revealed that the returned component does not exhibit any physical damage which might have cause the issue.Some physical scratches were noted on the face side of the liner.No deviations for material or processing indicated.The root cause of the connection problem could not be determined by this investigation.A dimensional evaluation noted that liner had features that could not be measured accurately due to damage that appeared to be from implantation attempts.The features that could be measured were to print specification.A clinical evaluation noted since the procedure was completed with a back-up liner, and no further harm is being alleged as a result of the two hour delay, thus no further clinical/medical assessment is warranted at this time.The device was manufactured in 2016.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: REF LNR 28X50-52 20 DEG SZ 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: 7480659
• Report Number: 1020279-2018-00839
• Device Sequence Number: 10811703
• Product Code: LPH
• UDI-Device Identifier: 03596010232267
• UDI-Public: 03596010232267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K932755
• 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): 11/22/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2026
• Device Catalogue Number: 71742850
• Device Lot Number: 16EM11863
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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: Other