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

Catalog Number	71333335
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor implanted the ref cup during the operation then opened the insert while it couldn't get into the cup.Under the condition that the product code was consistent with the outer cup, it was always not in place.The staff temporarily took a new set of products, but it was still can not be implanted.The doctor tried to take the product out of the body, and the insert and the cup were not in place outside the body.Finally a new outer cup was opened and the insert was rigidly implanted.
Additional Manufacturer Narrative
The affected reflection xlpe microstable acetabular liner was returned and evaluated.A visual inspection found deformation and gouges from attempted use on the articular section of the device.A dimensional was performed and found the damage/deformation at some features of the device would not allow for accurate measurement.All other measurable features are to be within manufacturing specifications.A clinical evaluation noted that based on the product evaluation the root cause of the connection problem was likely due to an error in trying to implant the smith and nephew device and not the performance of the smith and nephew device itself.It was further reported that neither the delay in the procedure nor a functional issue in the implant resulted in any harm or adverse patient outcome.Since the procedure was completed with a back-up and no further harm is being alleged as a result of the two hour delay, no further clinical/medical assessment is warranted.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2016.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or 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 AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7855516
• Report Number: 1020279-2018-01746
• Device Sequence Number: 1938840
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 71333335
• Device Lot Number: 16MM15842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 70