MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREE HOLE SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	71336454
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2018, 9:00 am, in linfen orthopedic hospital during a total hip replacement, after a 54mm reflection sp3 acetabular cup was implanted, found the 54-56/28mm liner cannot match with the 54mm cup.So removed the 54mm cup, changed to implanted a 56mm reflection sp3 acetabular cup, and the 54-56/28mm liner was implanted successfully, the surgery was completed.90min delay was reported, and increased the patient blood loss.
Additional Manufacturer Narrative
The associated ref 3 hole shell was returned and evaluated.Visual examination of the product by the lab found some scratches on the id surface of the shell.No other marks found.The od porous surface was examined visually with no scratches or marks found.Dimensional inspection of the shell indicated that all dimensions were within specifications.There is no evidence of deviations for material or manufacturing processes.A clinical evaluation noted that based on the available information, a root cause for the fitting problem cannot be concluded.No injury or harm was reported, secondary to the extended surgery time except for the increased blood loss which was mitigated by the autologous transfusion.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: REF THREE HOLE SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7509695
• Report Number: 1020279-2018-00915
• Device Sequence Number: 11228171
• Product Code: MBL
• UDI-Device Identifier: 03596010454362
• UDI-Public: 03596010454362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71336454
• Device Lot Number: 17DM1648A
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/13/2018
• Supplement Report FDA Received Date: 11/20/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 63